Flibanserin

70% of women diagnosed with breast cancer report having sexual dysfunction, this includes disorders of sexual desire and sexual response. RALEIGH, N.C., June 2, 2023 /PRNewswire/ -- Sprout Pharmaceuticals, Inc. a pharmaceutical company specializing in women's sexual health today announced publication of abstract 12015 by the American Society of Clinical Oncology (ASCO). The abstract reporting positive interim results for the use of Addyi (flibanserin) tablets in breast cancer patients with low libido has been accepted for presentation in a Poster Discussion Session at the ASCO 2023 Annual Meeting being held virtually and in Chicago, IL from June 2-6, 2023. The abstract is now available online on the ASCO conference website: Details of the poster presentation are as follows: Abstract Number: 12015 Poster Board Number: 383 Poster Title: Effect of flibanserin on libido in women with breast cancer on adjuvant endocrine therapy. Presenting Author: Shari Goldfarb, MD Session: Symptoms and Survivorship Date and Time: 6/5/2023, 4:30 PM-6:00 PM (CT) It is estimated that 70% of women diagnosed with breast cancer report having sexual dysfunction; this includes disorders of sexual desire and sexual response, yet there are no FDA-approved medications for women with HSDD secondary to cancer or its treatment. Dr. Shari Goldfarb, a breast medical oncologist from Memorial Sloan Kettering Cancer Center and the study's primary investigator said, "Decreased libido is an extremely prevalent, undertreated and distressing symptom in women with breast cancer on endocrine therapy. As investigators, we wanted to conduct a study to help treat decreased libido. This study evaluated the impact of flibanserin on decreased libido in women with breast cancer on endocrine therapy and shows that Flibanserin can be used safely and effectively in women with breast cancer. Flibanserin showed statistically significant improvement in not only libido, but also in the sexual domains of arousal, lubrication and ability to orgasm. Flibanserin should be offered to women with breast cancer with bothersome and medication-induced decreased libido. Having a medication to treat this often unaddressed issue will improve the quality of life and sexual function of millions of women with breast cancer." Cindy Eckert, CEO of Sprout Pharmaceuticals said, "Our mission at Sprout is to improve the lives of women by addressing their sexual health challenges. Seeing these interim results for Addyi in the breast cancer population is an important step in that mission." About the Investigator-Initiated Study The investigator-initiated prospective, observational study is being conducted through Memorial Sloan Kettering Cancer Center. A planned total of 43 women will be enrolled in the study from both an academic center and an alliance community site. The primary endpoint of this study is to evaluate the feasibility of flibanserin 100 mg orally at bedtime for 24 weeks in women with breast cancer on endocrine therapy. Secondary endpoints include the efficacy of flibanserin as measured by the number of SSEs per month, change in desire, change in sexual function, quality of life, and distress from sexual function. Additional information is available at . ABOUT SPROUT PHARMACEUTICALS Sprout Pharmaceuticals, Inc. is passionate about women's sexual health. Based in Raleigh, N.C., the company is focused solely on the delivery of a treatment option for women with HSDD. For more information call 1-844-PINK-PILL (1-844-746-5745). ABOUT ADDYI Addyi is an FDA-approved non-hormonal pill for acquired, generalized hypoactive (low) sexual desire disorder (HSDD) in certain premenopausal women. INDICATION What is ADDYI (add-ee) (flibanserin) Tablets? ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: a medical or mental health problem problems in the relationship medicine or other drug use. ADDYI is not for use for the treatment of HSDD in women who have gone through menopause, in men or in children. ADDYI is not for use to enhance sexual performance. IMPORTANT SAFETY INFORMATION What is the most important information I should know about ADDYI? Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take ADDYI and: drink alcohol close in time to when you take your ADDYI dose. Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime Examples of 1 standard alcoholic drink include: one 12-ounce regular beer, 5 ounces of wine, 1.5 ounces of distilled spirits or shot If you drink 3 or more standard alcoholic drinks in the evening, skip your ADDYI dose at bedtime. After you have taken your ADDYI at bedtime, do not drink alcohol until the following day. take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking ADDYI until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI. have liver problems. Do not take ADDYI if you have liver problems. If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you feel like you could faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can. Who should not take ADDYI? Do not take ADDYI if you: take certain medicines. Taking ADDYI with certain other medicines can increase the amount of ADDYI in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness. Do not take ADDYI if you are taking any of the following medicines: Certain medicines used to treat HIV-1 infection Certain medicines that you take by mouth used to treat fungal infections Certain antibiotics Certain medicines used to treat Hepatitis C infection Certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems Nefazodone: a medicine used to treat depression Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above. These are examples of the medicines that you should not take if you are taking ADDYI. Tell your doctor about all the medicines you take before you start taking ADDYI have liver problems are allergic to flibanserin or any of the ingredients in ADDYI. See Medication Guide for the full list of ingredients. What should I tell my doctor before taking ADDYI? Before you take ADDYI, tell your doctor about all of your medical conditions, including if you: drink alcohol, use drugs, or have a history of alcohol or drug abuse have ever had depression or other mental health problems have low blood pressure or a medical condition that can cause low blood pressure are pregnant or plan to become pregnant. It is not known if ADDYI will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ADDYI passes into your breast milk. You and your doctor should decide if you will take ADDYI or breastfeed. You should not do both. Tell your doctor if you have had an allergic reaction such as hives, itching, or trouble breathing during or after receiving a dose of ADDYI. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADDYI can affect the way other medicines work, and other medicines can affect the way ADDYI works, and can cause serious side effects. What should I avoid while taking ADDYI? Do not drink alcohol close to the time you take your ADDYI dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness). Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you. Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness). You should not take the herbal supplements St. John's Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking ADDYI with these herbal supplements and over-the-counter medicines may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness. What are the possible side effects of ADDYI? ADDYI can cause serious side effects, including: Sleepiness is a common side effect of ADDYI and can be serious. Taking ADDYI can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements. Low blood pressure and fainting (loss of consciousness) can happen when you take ADDYI even if you do not drink alcohol or take other medicines or herbal supplements. Your risk of low blood pressure and fainting (loss of consciousness) is increased if ADDYI is taken during waking hours, if you drink alcohol within 2 hours of taking ADDYI, or if you take certain medicines or herbal supplements. The most common side effects of ADDYI include: These are not all of the possible side effects of ADDYI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information, including Boxed Warning regarding severe low blood pressure and fainting in certain settings, and Medication Guide at addyi.com/pi. This information does not take the place of talking with your doctor. CONTACT INFORMATION info@sproutpharma.com 844-746-5745 x 2000 US—2300041.01 View original content to download multimedia: SOURCE Sprout Pharmaceuticals

PAXLOVID is the first FDA-approved oral treatment for COVID-19; has been authorized for emergency use since December 2021 Approval is based on the totality of scientific evidence submitted, including efficacy data from the Phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalization or death from any cause in patients who took PAXLOVID within five days of symptom onset PAXLOVID remains available to eligible patients via prescription at no charge* NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk pro indication for use in eligible adults remain consistent with the EUA. More than 11.6 million treatment courses of PAXLOVID have been prescribed in the U.S. to date.1 “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. This is especially true for the hundreds of millions of American adults who are age 50 or older or are otherwise at high risk for progression to severe illness, even if symptoms are initially mild,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Today marks a monumental milestone as PAXLOVID became the first COVID-19 oral treatment to be approved by the U.S. FDA, underscoring the value it brings to patients, providers, and health systems alike.” COVID-19 continues to cause significant burden in the U.S. with approximately 14,500 reported cases each week as of the end of April 2023;2 but the majority of cases are not reported.3 In addition, data show that the impact of COVID-19 extends beyond an acute infection; an estimated 10-31 million Americans may experience persisting, recurring or new symptoms after the acute phase of COVID-19 infection.4,5 The FDA approval of PAXLOVID is based on the totality of scientific evidence shared by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program. This included results from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study, which enrolled unvaccinated, non-hospitalized adults, aged 18 years and older, with confirmed COVID-19 who were at increased risk of progressing to severe disease. The data showed an 86% reduction in risk of COVID-19-related hospitalization or death from any cause through Day 28 in patients who initiated treatment with PAXLOVID within five days of symptoms onset, compared to placebo. The FDA approval was further supported by the results from a secondary endpoint of the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study, which showed a numerical reduction in COVID-19-related hospitalizations or death from any cause through Day 28 in a sub-group of non-hospitalized adults, aged 18 years and older, with confirmed COVID-19 who had at least one risk factor for progression to severe disease and who were fully vaccinated. Available safety data have been consistent in participants across the EPIC clinical program, as well as across reported post-authorization safety experience in millions of patients prescribed PAXLOVID to date. Recent real-world studies of PAXLOVID support the efficacy conclusions from Pfizer’s EPIC clinical program, providing additional data on the use of PAXLOVID in the post-authorization setting of Omicron sub-lineage predominance and where high levels of pre-existing immunity occur. These real-world studies also have shown that PAXLOVID is effective amongst both vaccinated and unvaccinated high-risk patients.6,7,8,9,10 Based on the relative risk reduction seen across both clinical and real-world data, the FDA provided an estimate in March 2023 that more than 1,500 lives could be saved, and 13,000 hospitalizations avoided each week with PAXLOVID use in eligible patients.11 At this time, the U.S. government will continue to oversee the distribution of PAXLOVID, and U.S. residents eligible for PAXLOVID will continue to receive the medicine at no charge.* PAXLOVID remains available for eligible children, 12 to 17 years of age (and weighing at least 40 kg), under the existing EUA. Pfizer continues to gather pediatric data from the ongoing clinical trial, EPIC-Peds (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) and intends to submit a supplemental New Drug Application (sNDA) to support the FDA approval of PAXLOVID in children at a future date. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness. *Other administrative fees may apply About PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir, which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus. Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has consistently shown in vitro antiviral activity against the variants Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, BA.2, BA.2.12.1, BA.4, BA.4.6, BA.5, BF.7, BQ.1.11, BQ.1 and XBB.1.5. Work is ongoing to evaluate activity against recently identified variants as they become available for testing. PAXLOVID is generally administered at a standard dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One standard dose carton contains blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The modified dose for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is reduced to 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet), with both tablets taken together twice daily for five days (PAXLOVID is not recommended in patients with severe renal impairment [eGFR <30 mL/min]). For more information, please visit . Our Commitment to Access Pfizer is committed to working toward equitable access to our oral COVID-19 treatment, PAXLOVID, for high-risk patients in need. Pfizer has established a comprehensive strategy in close partnership with worldwide governments, international global health leaders, including WHO’s Access to COVID-19 Tools Accelerator (ACT-A), and global manufacturers to optimize supply and access of PAXLOVID all around the world. This includes: Multilateral Supply Agreements: Signed agreement with UNICEF to supply up to 4 million treatment courses of PAXLOVID to 137 low- and middle-income countries; Signed letter of intent with Global Fund for up to 6 million PAXLOVID treatment courses for supply to 132 Global-Fund eligible countries. Expanding Access to Patent-Protected Medicines in Lower-Income Countries: Launched An Accord for a Healthier World, to support access for PAXLOVID and many other medicines and vaccines in lower-income countries. In addition to offering the full portfolio of medicines and vaccines for which we hold global rights on a not-for-profit-bases to 45 lower-income countries, through the Accord, Pfizer has committed to collaborate with country governments and global health organizations to help address barriers to access for these medicines and vaccines – like diagnostics, training, storage and more – to get PAXLOVID and other medicines to patients who need them in these countries. Voluntary Licensing: Signed a voluntary license agreement with Medicines Patent Pool (MPP) for the oral COVID-19 treatment to help expand access, pending country regulatory authorization or approval, for approximately 53% of the world’s population. The 35 generics manufacturers will develop generic versions of Pfizer’s COVID-19 oral treatment for distribution to 95 low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years, subject to approval or authorization. U.S. Indication PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Limitations of Use PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. U.S. FDA Emergency Use Authorization Statement The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the emergency use of mild- to‑moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID‑19, including hospitalization or death. PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. IMPORTANT SAFETY INFORMATION WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events Prior to prescribing PAXLOVID: 1) Review all medications taken by the patient to assess potential drug-drug interactions with a strong CYP3A inhibitor like PAXLOVID and 2) Determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care. PAXLOVID is contraindicated with drugs that are primarily metabolized by CYP3A and for which elevated concentrations are associated with serious and/or life-threatening reactions and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended. Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor like PAXLOVID. Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions: Alpha 1-adrenoreceptor antagonist: alfuzosin Antianginal: ranolazine Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine Anti-gout: colchicine (in patients with renal and/or hepatic impairment) Antipsychotics: lurasidone, pimozide Benign prostatic hyperplasia agents: silodosin Cardiovascular agents: eplerenone, ivabradine Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use) Immunosuppressants: voclosporin Microsomal triglyceride transfer protein inhibitor: lomitapide Migraine medications: eletriptan, ubrogepant Mineralocorticoid receptor antagonists: finerenone Opioid antagonists: naloxegol PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension Sedative/hypnotics: triazolam, oral midazolam Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin Vasopressin receptor antagonists: tolvaptan Drugs that are strong CYP3A inducers: PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer: Anticancer drugs: apalutamide Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin Antimycobacterials: rifampin, rifapentine Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor Herbal Products: St. John’s Wort (hypericum perforatum) Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, which contains ritonavir, a strong CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Medications that induce CYP3A may decrease concentrations of PAXLOVID. These interactions may lead to: Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications Loss of therapeutic effect of PAXLOVID and possible development of viral resistance Severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID. The most commonly reported concomitant medications resulting in serious adverse reactions were calcineurin inhibitors (eg, tacrolimus, cyclosporine), followed by calcium channel blockers. Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Because nirmatrelvir is coadministered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection. The most common adverse reactions in the PAXLOVID group (≥1%) that occurred at a greater frequency than in the placebo group were dysgeusia (5% and <1%, respectively) and diarrhea (3% and 2%, respectively). The following adverse reactions have been identified during use of PAXLOVID under Emergency Use Authorization: Immune System Disorders: Anaphylaxis, hypersensitivity reactions Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome Nervous System Disorders: Headache Vascular Disorders: Hypertension Gastrointestinal Disorders: Abdominal pain, nausea, vomiting General Disorders and Administration Site Conditions: Malaise PAXLOVID is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp, and OATP1B1. Coadministration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Coadministration with other CYP3A substrates may require a dose adjustment or additional monitoring. Pregnancy: Available data on the use of nirmatrelvir during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data report that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. Pediatrics: The optimal dose of PAXLOVID has not been established in pediatric patients. Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. No dosage adjustment is recommended in patients with mild renal impairment. Reduce the dose of PAXLOVID in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min) or in patients with end-stage renal disease (eGFR <15 mL/min). PAXLOVID is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Please see Full Prescribing Information, including BOXED WARNING and Patient Information Click for Fact Sheets: There may be a delay as the documents are updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly. For Consumers: EUA Fact sheet for Patients, Parents, and Caregivers For Healthcare Professionals: EUA Fact Sheet for HCPs About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of May 25, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s efforts to combat COVID-19 and PAXLOVID (including an approval in the U.S. of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death, intention to submit a supplemental New Drug Application to support the FDA approval of PAXLOVID in children at a future date, the transition to a more traditional U.S. commercial model, efforts toward equitable access, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability pro to date, in additional studies or in larger, more diverse populations following commercialization; uncertainties regarding the commercial impact of the results of the EPIC-SR and EPIC-PEP trials; the ability of PAXLOVID to maintain efficacy against emerging virus variants; the risk that serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for PAXLOVID or any of Pfizer’s other products or product candidates may be filed in particular jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any applications or submissions for PAXLOVID or any of Pfizer’s other products or product candidates that may be pending or which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PAXLOVID or any of Pfizer’s other products or product candidates, including the authorization or approval of products or therapies developed by other companies; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test PAXLOVID; manufacturing capabilities or capacity; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of PAXLOVID within the projected time periods; whether and when additional purchase agreements will be reached or existing agreements will be completed or re-negotiated; challenges related to a transition to the commercial market for PAXLOVID; the risk that demand for any products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on-hand and/or in the channel or reduced revenues; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . __________________________ 1 IQVIA National Prescription Audit data through May 05, 2023, containing retail pharmacy, mail order and long-term care channels; U.S. Department of Health and Human Services data through February 2023, for non-retail channels. Note: This information is an estimate derived from the use of information under license from the following IQVIA information service: National Prescription Audit, for the period January 1, 2022-May 05, 2023. IQVIA expressly reserves all rights, including rights of copying, distribution and republication. 2 Covid Data Tracker Weekly Review. Centers for Disease Control and Prevention. (2023, April 14). Retrieved April 27, 2023, from 3 Estimated COVID-19 burden. (2022). Retrieved from . 4 Davis HE, McCorkell L, Vogel JM, et al. Long COVID: major findings, mechanisms and recommendations. Nature Reviews Microbiology. 2023;21(3):133-46. 5 Bull-Otterson L, Baca S, Saydah S, et al. Post–COVID conditions among adult COVID-19 survivors aged 18–64 and≥ 65 years—United States, March 2020–November 2021. Morbidity and Mortality Weekly Report. 2022;71(21):713-17. 6 Lewnard JA, McLaughlin JM, Malden D, et al. Effectiveness of nirmatrelvir-ritonavir against hospital admission or death: a cohort study in a large US healthcare system. Lancet ID: (23)00118-4 7 Ganatra S, Dani SS, Ahmad J, et al. Oral Nirmatrelvir and Ritonavir in Non-hospitalized Vaccinated Patients with Covid-19 [published online ahead of print, 2022 Aug 20]. Clin Infect Dis. 2022;ciac673. doi:10.1093/cid/ciac673 8 Aggarwal NR, Molina KC, Beaty LE, et al. Real-world use of nirmatrelvir–ritonavir in outpatients with COVID-19 during the era of omicron variants including BA.4 and BA.5 in Colorado, USA: a retrospective cohort study. The Lancet Infectious Diseases 2023. DOI: (23)00011-7. 9 Shah MM, Joyce B, Plumb ID, et al. Paxlovid Associated with Decreased Hospitalization Rate Among Adults with COVID-19 — United States, April–September 2022. MMWR Morb Mortal Wkly Rep 2022;71:1531–1537. DOI: . 10 Dryden-Peterson S, Kim A, Kim AY, Caniglia EC, Lennes IT, Patel R, Gainer L, Dutton L, Donahue E, Gandhi RT, Baden LR, Woolley AE. Nirmatrelvir Plus Ritonavir for Early COVID-19 in a Large U.S. Health System : A Population-Based Cohort Study. Ann Intern Med. 2023 Jan;176(1):77-84. doi: 10.7326/M22-2141. Epub 2022 Dec 13. PMID: 36508742; PMCID: PMC9753458. 11 U.S. Food and Drug Administration. Treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Antimicrobial Drugs Advisory Committee Meeting. Briefing Document. Reference data as of January 2023. Available at: March 16, 2023 Meeting of the Antimicrobial Drugs Advisory Committee Meeting (fda.gov). Accessed: May 4, 2023.