Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2 Detailed OUtMATCH results will be featured in a late-breaking symposium at the 2024 AAAAI Annual Meeting
"Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result. Today's approval of Xolair represents a paradigm shift in the way food allergies can be managed," said Reshema Kemps-Polanco, Executive Vice President and Chief Commercial Officer, Novartis US. "This approval, which comes 20 years after the first approval for this medicine, shows that we never stop innovating to make a meaningful difference for patients living with immunological conditions." The FDA approval is based on positive data from the Phase III OUtMATCH study, which evaluated Xolair in patients aged 1 to 55 years allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut. The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID)Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is being conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10 clinical sites across the US led by Johns Hopkins Children's Center and co-led by Stanford School of Medicine. Detailed results from the study will be featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI)Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Sunday, February 25. "As more and more people are affected by food allergies, the need for a new approach to help prevent serious and often life-threatening allergic reactions and emergencies is critical," said Sung Poblete, R.N., Ph.D., CEO of FARE (Food Allergy Research and Education). "As someone with food allergies, I know firsthand the significant impact they can have on people and their loved ones, and I share in the community's excitement for this approval." "The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children's birthday parties, school lunches, and holiday dinners with friends and family," said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA). "Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies." Patients entered the OUtMATCH study unable to tolerate up to 100 mg of peanut protein (equivalent to about one third of a peanut), and up to 300 mg each of milk, egg and cashew protein. After 16 to 20 weeks of treatment with Xolair or placebo, each participant completed four food challenges, receiving gradually increasing amounts of foods they are allergic to (and a placebo ingredient), in order to assess their ability to consume a single dose of at least 600 mg of peanut protein (primary endpoint), and a single dose of at least 1,000 mg of milk, egg or cashew protein (secondary endpoints) without experiencing moderate to severe allergic symptoms. Study results showed a statistically significant higher proportion of patients (68%) treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo (p4. The most common adverse events (≥3% of patients) in Xolair-treated patients in the study were injection site reaction (15.5% vs. 10.9% with placebo) and fever (6.4% vs. 3.6% with placebo). Xolair is a prescription biologic medicine that is given as an injection under the skin (subcutaneous). It is the only FDA-approved antibody designed to target and block IgE — an underlying driver of food allergy reactions. The recommended Xolair dosage for treatment of food allergy is 75 mg to 600 mg once every 2 or 4 weeks. Xolair dose and dosing frequency is determined by total serum IgE level and body weight. Injections can be given by a healthcare provider in a healthcare setting or at home through self-injection after initiating in a healthcare setting. Healthcare providers will determine appropriate candidates for self-injection. Genentech and Novartis are committed to helping people access the medicines they are prescribed and offer comprehensive services for people prescribed Xolair to help minimize barriers to access and reimbursement. More information is available at 866-4ACCESS/866-422-2377. The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is a three-stage, multicenter, randomized, double-blind, placebo-controlled study evaluating Xolair safety and efficacy in patients aged 1 to 55 years who are allergic to peanuts and at least two other food allergens. Stage 1 patients were randomized to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. The Xolair dose and dosing interval were determined by total serum immunoglobulin E (IgE) level and body weight at baseline. After 16 to 20 weeks of treatment with Xolair or placebo, each participant completed four separate blinded food challenges where they were given gradually increasing amounts of peanut protein, two other food proteins they were allergic to, and a placebo ingredient. The food challenges were conducted in a carefully controlled setting with investigators looking for signs and symptoms of allergic reaction to assess patients' ability to consume a single dose of at least 600 mg of peanut protein (primary endpoint), and a single dose of at least 1,000 mg of milk, egg, wheat, cashew, hazelnut or walnut protein (secondary endpoints) without experiencing dose-limiting symptoms, which were defined as moderate to severe allergic symptoms, including skin, respiratory or gastrointestinal symptoms. In the US, Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. Indications and Important Safety Information
XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat: moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age. food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age. IMPORTANT SAFETY INFORMATION
What is the most important information I should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom" swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions,
are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I receive and use XOLAIR? When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting. If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR. Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver. See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR. XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks. In people with asthma, CRSwNP and food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency. In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. Do not decrease or stop taking any of your other asthma, CRSwNP, hive medicine, food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider. If you inject more XOLAIR than prescribed, call your healthcare provider right away. What are the possible side effects of XOLAIR? XOLAIR may cause serious side effects, including: Cancer. Cases of cancer were observed in some people who received XOLAIR. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider. The most common side effects of XOLAIR: These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects. for additional Important Safety Information and
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