Colchicine

Phase 3 OASIZ-301 Study of Dazodalibep in Sjögren's Disease Shows Statistically Significant and Clinically Meaningful Improvement in Systemic Disease Activity and Patient-Reported Dryness New Long-Term UPLIZNA Data in IgG4-Related Disease and Real-World Evidence for KRYSTEXXA and TAVNEOS Further Highlight Amgen's Broad Portfolio and Commitment to People Living with Rare Diseases THOUSAND OAKS, Calif. , Oct. 27, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced plans to present new data across its portfolio, including in rare and other serious autoimmune diseases at the American College of Rheumatology (ACR) Convergence 2026. Key presentations include: Dazodalibep Significantly Reduces Systemic Disease Activity in Patients with Sjögren’s Disease and Moderate-to-Severe Disease Activity: Results from the Phase 3 OASIZ-301 Trial Late-Breaking Abstract #22, Wednesday, November 11, from 8:45–9:00 a.m. ET Sjögren's disease is a systemic autoimmune disease that can affect the entire body. Along with symptoms of extensive dryness, other serious manifestations may include profound fatigue, chronic pain, major organ involvement, neuropathy, and an increased risk of lymphoma. There are currently no FDA-approved medicines for Sjögren's disease. Amgen will present late-breaking results from the Phase 3 OASIZ-301 study evaluating dazodalibep in adults living with Sjögren's disease and moderate-to-severe systemic disease activity. Dazodalibep is a CD40L antagonist that disrupts interactions between T cells, glandular epithelial cells, B cells and other antigen-presenting cells. Patients entered the OASIZ-301 study with an average European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of 10.2. Results show that at Week 48 both dazodalibep dosing regimens (1,500 mg every four weeks and 3,000 mg every 12 weeks) demonstrated statistically significant and clinically meaningful reductions in systemic disease activity compared with placebo. Treatment effects were observed as early as four weeks. Disease activity scores improved by a least-squares mean change from baseline of -5.6 points in patients receiving dazodalibep every four weeks (difference vs placebo, −1.8; adjusted p3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease. Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established. Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming. Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common. ADVERSE REACTIONS The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. DRUG INTERACTIONS Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS. Co‑administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS. TAVNEOS is available as a 10 mg capsule. Please see Full Prescribing Information and Medication Guide for TAVNEOS. To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting or calling 1-800-332-1088. KRYSTEXXA (pegloticase) U.S. INDICATION KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.  Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.  KRYSTEXXA (pegloticase) U.S. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA. Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Life threatening hemolytic reactions and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency. CONTRAINDICATIONS: In patients with G6PD deficiency.  In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.  WARNINGS AND PRECAUTIONS Anaphylaxis In a 52-week controlled trial of KRYSTEXXA co-administered with methotrexate (MTX) compared to KRYSTEXXA alone, one patient treated with KRYSTEXXA co-administered with MTX (1%) experienced anaphylaxis during the first infusion and no patients experienced anaphylaxis treated with KRYSTEXXA alone. Patients were pre-treated with infusion reaction prophylaxis and KRYSTEXXA was discontinued following 2 consecutive serum uric acid levels above 6 mg/dL to reduce the risk of anaphylaxis and infusion reactions. These risks are higher in patients whose uric acid level increases to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.   During pre-marketing clinical trials with KRYSTEXXA alone, KRYSTEXXA was not discontinued following 2 consecutive serum uric acid levels above 6 mg/dL. Anaphylaxis was reported with 6.5% (8/123) of patients treated with KRYSTEXXA every 2 weeks and 4.8% (6/126) for the every 4-week dosing regimen. There were no cases of anaphylaxis in patients receiving placebo. Anaphylaxis generally occurred within 2 hours after treatment.  Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to KRYSTEXXA or placebo injection with no other identifiable cause. Manifestations included wheezing, peri-oral or lingual edema, or hemodynamic instability, with or without rash or urticaria, nausea or vomiting. Cases occurred in patients being pre-treated with one or more doses of an oral antihistamine, an intravenous corticosteroid and/or acetaminophen, which may have resulted in an underestimate of anaphylaxis frequency reported. Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.  It is recommended that before starting KRYSTEXXA patients discontinue oral urate-lowering medications and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.  Infusion Reactions In the 52-week trial, infusion reactions were reported in 4% of patients in the KRYSTEXXA co-administered with MTX group compared to 31% of patients treated with KRYSTEXXA alone. In both treatment groups, the majority of infusion reactions occurred at the first or second KRYSTEXXA infusion and during the time of infusion. During pre-marketing 24-week controlled clinical trials with KRYSTEXXA alone, infusion reactions were reported in 26% of patients treated with KRYSTEXXA 8 mg every 2 weeks, and 41% of patients treated with KRYSTEXXA 8 mg every 4 weeks, compared to 5% of patients treated with placebo. These infusion reactions occurred in patients being pre-treated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen, which may have resulted in an underestimate of infusion reaction frequency reported.  Manifestations of these reactions included urticaria (10.6%), dyspnea (7.1%), chest discomfort (9.5%), chest pain (9.5%), erythema (9.5%), and pruritus (9.5%). These manifestations overlap with the symptoms of anaphylaxis, but in a given patient did not occur together to satisfy the clinical criteria for diagnosing anaphylaxis. Infusion reactions occurred at any time during a course of treatment with ~3% occurring with the first infusion, and ~91% occurred during the time of infusion.  KRYSTEXXA should be infused slowly over no less than 120 minutes. In the event of an infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.  Gout Flares In the 52-week trial of KRYSTEXXA co-administered with MTX vs KRYSTEXXA alone, patients were administered gout flare prophylaxis, resulting in 66% and 69% of patients with any flare for the first 3 months, respectively. In the KRYSTEXXA co-administered with MTX group, the percentages of patients with any flare for the subsequent 3 month increments of treatment were 27%, 8%, and 9% during Months 6, 9, and 12, respectively; in the group treated with KRYSTEXXA alone, 14%, 9%, and 21% during Months 6, 9, and 12, respectively. During the 24-week pre-marketing, controlled trials, with KRYSTEXXA alone the frequencies of gout flares were high in all treatment groups, but more so with KRYSTEXXA treatment during the first 3 months, and decreased in the subsequent 3 months. The percentages of patients with any flare for the first 3 months were 74%, 81%, and 51%, for KRYSTEXXA 8 mg every 2 weeks, KRYSTEXXA 8 mg every 4 weeks, and placebo, respectively. The percentages of patients with any flare for the subsequent 3 months were 41%, 57%, and 67%, for KRYSTEXXA 8 mg every 2 weeks, KRYSTEXXA 8 mg every 4 weeks, and placebo, respectively. Patients received gout flare prophylaxis with colchicine and/or NSAIDs starting at least one week before receiving KRYSTEXXA. Gout flares may occur after initiation of KRYSTEXXA. An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Gout flare prophylaxis with a NSAID or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. KRYSTEXXA does not need to be discontinued because of a gout flare. The gout flare should be managed concurrently as appropriate for the individual patient.  Congestive Heart Failure (CHF) KRYSTEXXA has not been formally studied in patients with CHF, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Two cases of CHF exacerbation occurred during the trials in patients receiving treatment with KRYSTEXXA 8 mg every 2 weeks. No cases were reported in placebo-treated patients. Four subjects had exacerbations of pre-existing CHF while receiving KRYSTEXXA 8 mg every 2 weeks during the OLE study. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion. Re-treatment with KRYSTEXXA No controlled trial data are available on re-treatment after stopping treatment for longer than 4 weeks. Due to the immunogenicity of KRYSTEXXA, patients receiving re-treatment may be at increased risk of anaphylaxis and infusion reactions. Therefore, patients receiving re-treatment after a drug-free interval should be monitored carefully.  ADVERSE REACTIONS The most common adverse reactions (≥5%) are:  Co-administration with MTX: Gout flares, arthralgia, COVID-19, nausea, and fatigue.  KRYSTEXXA alone: Gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting . Please see Full Prescribing Information , including Boxed Warning. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube , Facebook , TikTok and Threads . 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A pooled analysis from the global SCORPIO clinical program showed potent antiviral activity with ensitrelvir across age, vaccination status and risk for severe disease New data underscores that even mild-to-moderate COVID-19 may worsen and exacerbate underlying chronic conditions, supporting the importance of prevention OSAKA, Japan--(BUSINESS WIRE)--Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) will present new exploratory analyses from the global Phase 3 SCORPIO-PEP study, virology data from across the ensitrelvir phase 3 program, and new insights on the continued burden of COVID-19 at IDWeek 2026. XOCOVA ® (ensitrelvir) was approved in May 2026 by the U.S. Food and Drug Administration (FDA) for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. 1 The approval was based on positive results from SCORPIO-PEP, a global, double-blind, randomized, placebo-controlled Phase 3 study. In the primary analysis population, XOCOVA significantly reduced the risk of developing symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011). 1,2 In SCORPIO-PEP, XOCOVA was generally well tolerated, with similar rates of adverse events across groups (15.1% in the ensitrelvir group (n=1,190) and 15.5% in the placebo group (n=1,187)). 2 The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough. 1,2 There were no reports of altered taste (dysgeusia) attributed to XOCOVA in the trial. 2,3 Exploratory SCORPIO-PEP Analyses Describe Symptom Severity and Viral Outcomes Among Participants with Breakthrough Infection or Infection Present at Baseline In an oral presentation at IDWeek 2026, Shionogi will report new exploratory analyses from the SCORPIO-PEP study evaluating participants who had breakthrough infections or were already infected at baseline. 4 Among breakthrough infection cases (based on RT-PCR positivity regardless of symptoms) in the primary analysis population, the mean maximum viral RNA levels were lower in participants receiving ensitrelvir compared to those receiving placebo (3.1 vs 4.3 mean log10 copies/mL, respectively, seen in 144 and 217 breakthrough infection cases, respectively). 4 In household contacts who were infected with SARS-CoV-2 at the time of enrollment (confirmed positive by baseline central RT-PCR despite testing negative on a local screening test and being asymptomatic; n=237), numerically lower mean viral RNA levels were also observed with ensitrelvir in comparison to placebo on Days 3 and 6. 4 In the primary analysis population, a numerically lower proportion of participants with symptomatic breakthrough infections taking ensitrelvir developed severe symptoms, compared with those taking placebo (severe symptoms were reported in 8/28 or 28.6% of individuals receiving ensitrelvir compared with 48/89 or 53.9% of individuals receiving placebo). 4 Similarly, numerically lower mean total symptom scores earlier in the study and lower mean maximum total symptom scores were observed in participants receiving ensitrelvir compared with placebo (mean maximum total scores were 6.6 vs 8.9 respectively). 4 In participants receiving ensitrelvir who were infected with SARS-CoV-2 at the time of enrollment despite testing negative on a local screening test and being asymptomatic, a numerically lower proportion developed severe symptoms compared with placebo (severe symptoms were reported in 2/18 or 11.1% of individuals receiving ensitrelvir compared with 9/24 or 37.5% of individuals receiving placebo). 4 Similarly, numerically lower mean total symptom scores earlier in the study and mean maximum total symptom scores were observed in those receiving ensitrelvir compared with placebo. 4 “SCORPIO-PEP showed that early administration of ensitrelvir following household exposure reduced the risk of symptomatic COVID-19,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development, Shionogi Inc. “This exploratory analysis provides additional insight into the antiviral activity of ensitrelvir on viral load and symptom outcomes among participants who developed COVID-19. These observations add to our understanding of the potential outcomes associated with early administration of ensitrelvir following household exposure.” Pooled Phase 3 Study Data Analysis Shows Potent Antiviral Activity of Ensitrelvir Through Observed Reductions in Infectious Virus In a separate poster presentation, investigators will report findings from a post-hoc pooled analysis of two Phase 3 studies designed to assess infectious-virus-based virologic outcomes across a broad range of participants with confirmed COVID-19 infection. 6 Unlike viral RNA detection by RT-PCR, which may identify noninfectious viral remnants, infectious-virus measurements assess the presence of replication-competent virus and can provide additional insight into antiviral activity. 5,6 By Day 4, participants who received ensitrelvir (375 mg on Day 1, then 125 mg on Days 2–5; n=484) had numerically greater reductions in infectious virus titers than those who received placebo (n=487) (difference in least-squares mean of 0.21 log10 TCID 50 /mL). 6 Similar results were observed across subgroups regardless of age, vaccination status, and risk factors for severe COVID-19. Also on day 4, a higher proportion of ensitrelvir recipients had undetectable infectious viral load compared to those receiving placebo (95.7% [463/484] vs 72.1% [351/487]). 6 “With data pooled from two Phase 3 studies, this analysis represents the most extensive infectious virus dataset reported for a COVID-19 antiviral to date, and it helps to further characterize ensitrelvir’s effect on active viral replication,” said Florin Draica, MD, CMD, MBA, Senior Vice President, U.S. Medical Affairs, Shionogi Inc. “Although these results are exploratory, the observed reductions in infectious virus provide additional support of ensitrelvir’s antiviral activity and warrant further evaluation of their potential implications for infectivity and transmission.” Systematic Literature Review Highlights the Continued Burden of COVID-19 and Its Impact on Underlying Chronic Conditions Shionogi will also present a systematic literature review evaluating the impact of acute COVID-19 on individuals with underlying chronic conditions during the Omicron era or in earlier time periods. The review included 35 observational studies assessing clinical outcomes, health-related quality of life (HRQoL), and healthcare resource utilization (HCRU). 7 Across the studies reviewed, acute COVID-19 was associated with worsening, exacerbation, or relapse of underlying chronic conditions spanning respiratory, neurologic, cardiovascular, renal, and other disease areas. 7 More than half of studies evaluating clinical outcomes (17 out of 33) reported statistically significant worsening of underlying chronic conditions such as asthma, COPD, multiple sclerosis and CKD, following acute COVID-19. 7 COVID-19 was also associated with worsening outcomes in five of eight studies reporting on HRQoL and increased hospitalization frequency or extended hospital length of stay in four of the six studies reporting on HCRU. 7 “Across studies in this review, acute COVID-19 during the Omicron predominance was associated with worsening or exacerbation of underlying chronic conditions. Specifically, we found that COVID-19 infection, even mild or moderate, was associated with reduced health-related quality of life and increased healthcare resource utilization,” said Alpesh N. Amin, M.D., Professor, Founding Chief and Executive Director of Hospital Medicine & Palliative Medicine, and Co-Director & Medical Director of the Institute for Precision Health at the University of California, Irvine. “These findings reinforce the continued burden of COVID-19 and underscore the importance of prevention, especially among people living with chronic conditions.” The Ongoing Impact of COVID-19 COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19. 8,9 The U.S. Centers for Disease Control and Prevention estimates that between October 1, 2025, and September 26, 2026, there were 5.2-14.6 million new cases in the U.S., resulting in 1.1-2.7 million outpatient visits, 170,000-270,000 hospitalizations and 17,000-48,000 deaths. 10 Beyond acute infection, COVID-19, even mild-to-moderate, may worsen underlying chronic conditions and can have lasting health impacts. Studies have reported increased rates of new and worsening neurologic, cardiovascular, respiratory, and chronic kidney conditions in the year following COVID-19 infection. 11-19 COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities. 20 About SCORPIO-PEP The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of XOCOVA as post-exposure prophylaxis for COVID-19. The study was conducted from June 2023-September 2024. It included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. More than 98% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both. Study participants were randomly assigned at a 1:1 ratio to receive XOCOVA (375 mg on Day 1 and 125 mg on Days 2-5) or placebo, once daily for five days, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Results from SCORPIO-PEP were published in the New England Journal of Medicine . SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual.* About XOCOVA XOCOVA ® (ensitrelvir) is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. XOCOVA suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. XOCOVA is approved in the U.S., Japan and European Union for post-exposure prophylaxis of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 in adults and adolescents 12 years of age and older. XOCOVA received supplemental approval in Japan in June 2026 for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. XOCOVA is not approved for the treatment of COVID-19 in the U.S. U.S. INDICATION XOCOVA (ensitrelvir) is a prescription medicine used to help prevent coronavirus disease 2019 (COVID-19) in adults and children aged 12 years and older following contact with a person who has COVID-19 (post-exposure prophylaxis). It is not known if XOCOVA is safe and effective in children under age 12. IMPORTANT SAFETY INFORMATION Do not take XOCOVA if you are: allergic to ensitrelvir or any of the ingredients in XOCOVA. take any of the following medicines, as these may interact with XOCOVA and may cause severe or life-threatening side effects or death: apalutamide, carbamazepine, colchicine, dihydroergotamine, enzalutamide, eplerenone, ergotamine, finerenone, ivabradine, lomitapide, lumacaftor/ivacaftor, lurasidone, methylergonovine, phenytoin, pimozide, quinidine, rifampin, St. John’s wort, simvastatin, triazolam or voclosporin. These are not the only medicines that may cause serious or life-threatening side effects if taken with XOCOVA. XOCOVA may increase or decrease the levels of many medicines in your body. Tell your healthcare provider (HCP) about all the medicines you take because additional laboratory tests or dose changes of your other medicines may be necessary during XOCOVA use. Your HCP may tell you about specific symptoms to watch for that may indicate you need to stop or decrease the dose of some of your other medicines. Before taking XOCOVA, tell your HCP about all your medical conditions, including if you: are pregnant or plan to become pregnant. XOCOVA may harm your unborn baby. For females who are able to become pregnant, your HCP will check with you to see if you are pregnant before starting XOCOVA. Use effective birth control (contraception) during XOCOVA use and for 2 weeks after the final dose. Tell your HCP right away if you become pregnant or think you may be pregnant during XOCOVA use. are breastfeeding or plan to breastfeed. It is not known if XOCOVA passes into your breast milk. Do not breastfeed during XOCOVA use and for 2 weeks after the final dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP can tell you if it is safe to take XOCOVA with other medicines. Do not start a new medicine without telling your HCP. What are the possible side effects of XOCOVA? XOCOVA may cause serious side effects, including: Allergic reactions, including severe allergic reactions (anaphylaxis). Stop taking XOCOVA and get medical help right away if you get any of the following allergic reaction symptoms: skin rash; hives; itching; swelling of the mouth, lips, tongue, or face; trouble swallowing or breathing; throat tightness; dizziness or feeling lightheaded; stomach-area (abdomen) pain; or vomiting. The most common side effects of XOCOVA include : headache, diarrhea, and cough. These are not all possible side effects of XOCOVA. For more info, ask your HCP or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 . Please see full Prescribing Information , including Patient Information , for XOCOVA. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company. Since 1878, Shionogi has been developing new treatments to improve patients’ lives worldwide. Today in North America, we are focused on infectious and rare diseases, and our portfolio includes an antibiotic for serious infections caused by susceptible Gram-negative bacteria, an oral antiviral for post-exposure prophylaxis of COVID-19 and a therapy for amyotrophic lateral sclerosis (ALS). Together with our subsidiaries Qpex Biopharma Inc. and Shionogi Canada Inc., we are continuing to innovate across infectious disease, rare disease and additional high‑need therapeutic areas. Learn more at shionogi.com . About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain and CNS disorders. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs, including rare diseases, allergy/inflammation, oncology, hearing loss, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. * Literature search conducted in May 2026 References 1 XOCOVA (ensitrelvir) Prescribing Information. Available from: . Accessed July 6, 2026. 2 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. N Engl J Med . 2026;394(19):1905-1915. doi: 10.1056/NEJMoa2509306 . 3 Hayden FG, Shinkai M, Clark TW, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. Supplementary Appendix. N Engl J Med . 2026;394(19). Available from: . 4 Fukushi A, Nobori H, Sakaguchi H, et al. Early Pre-Symptomatic Treatment with Ensitrelvir Among PCR-Positive, SARS-CoV-2-Exposed and Infected Household Contacts: SCORPIO-PEP Subpopulation Analysis. Presented at: IDWeek 2026; Washington, D.C., United States. 5 Binnicker MJ. Can Testing Predict SARS-CoV-2 Infectivity? The Potential for Certain Methods To Be Surrogates for Replication-Competent Virus. Journal of Clinical Microbiology . 2021;59(11):e00469-21. doi:10.1128/JCM.00469-21. 6 Hurt AC, Nobori H, Sakaguchi H, et al. Reduction of Infectious SARS-CoV-2 and Viral RNA with Ensitrelvir: A Pooled Analysis of SCORPIO-SR and SCORPIO-HR Trials [poster presentation]. Presented at: IDWeek 2026; Washington, D.C., United States. 7 Draica F, Verdi D, Fedele M, et al. Impact of Acute COVID-19 on Underlying Chronic Conditions:​ Systematic Literature Review [poster presentation]. Presented at: IDWeek 2026; Washington, D.C., United States. 8 Baker JM, Nakayama JY, O’Hegarty M, et al. Household transmission of SARS-CoV-2 in five US jurisdictions: comparison of Delta and Omicron variants. PLoS One. 2025;20(1):e0313680. doi:10.1371/journal.pone.0313680. 9 Madewell ZJ, Yang Y, Longini IM Jr, et al. Household secondary attack rates of SARS-CoV-2 by variant and vaccination status: an updated systematic review and meta-analysis. JAMA Netw Open. 2022;5(4):e229317. doi:10.1001/jamanetworkopen.2022.9317. 10 Centers for Disease Control and Prevention [Internet]. Preliminary 2025-2026 COVID-19 burden estimates. Available from: 11 Xie Y, Xu E, et al. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3. 12 Sax PE, Draica F, et al. New onset conditions, exacerbations and worsening of underlying conditions following COVID-19 infection [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 13 Graham EL, Clark JR, et al. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized COVID-19 “long haulers.” Ann Clin Transl Neurol. 2021;8(5):1073-1085. doi:10.1002/acn3.51350. 14 Xie Y, Xu E, Bowe B, et al. Risks of mental health outcomes in people with COVID-19: a cohort study. BMJ. 2022;376:e068993. doi:10.1136/bmj-2021-068993. 15 Srivastava S, Garg I. Post-COVID-19 infection: long-term effects on liver and kidneys. World J MetaAnal. 2021;9(3):220-233. doi:10.13105/wjma.v9.i3.220. 16 Tenforde MW, Kim SS, Lindsell CJ, et al. Symptom duration and risk factors for delayed return to usual health among outpatients with COVID-19 in a multistate health care systems network—United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(30):993-998. doi:10.15585/mmwr.mm6930e1. 17 Kwok WC, Chau CH, Tam TCC, et al. Outcomes among patients with chronic obstructive pulmonary disease after recovery from COVID-19 infection of different severity. Sci Rep. 2024;14(1):13881. doi:10.1038/s41598-024-64670-9. 18 Conway SE, Healy BC, Zurawski J, et al. COVID-19 severity is associated with worsened neurological outcomes in multiple sclerosis and related disorders. Mult Scler Relat Disord. 2022;63:103946. doi:10.1016/j.msard.2022.103946. 19 Chen IW, Chang LC, Ho CH, et al. Association between COVID-19 and the development of chronic kidney disease in patients without initial acute kidney injury. Sci Rep. 2025;15(1):10924. doi:10.1038/s41598-025-96032-4. 20 Gravenstein S, Cooke CE, Verdi D, et al. Current impact of COVID-19 in long-term care facilities in the United States: a systematic literature review. Sr Care Pharm. 2026;41(5):167-186. doi:10.4140/TCP.n.2026.167. Contacts For Further Information: SHIONOGI Website Inquiry Form: U.S. Media: ShionogiCommunications@shionogi.com Shionogi Europe Press Office: pressoffice@shionogi.eu