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FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

South San Francisco, CA -- February 16, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is widely available and can now be prescribed for appropriate patients with IgE-mediated food allergy in the U.S.

“Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens,” said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

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), 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 U.S. 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) 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 (p<0.0001). This amount is equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter.

In addition, a statistically significant higher proportion of patients treated with Xolair compared to placebo tolerated at least 1,000 mg of protein from milk (66% vs. 11%; p<0.0001), egg (67% vs. 0%; p<0.0001) or cashew (42% vs. 3%; p<0.0001) without moderate to severe allergic symptoms. This amount is equivalent to approximately two tablespoons of 1% milk, one-quarter of an egg or three and a half cashews. While patients in the study tolerated these amounts of food, treatment with Xolair should be used with continued food allergen avoidance.

Safety findings were consistent with the known safety profile of Xolair across its additional indications and in previous clinical trials. 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).

About 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies, based on estimates for 2024. Food allergy prevalence has been on the rise for the past 20 years. There are 160 different foods that cause IgE-mediated food allergy. Allergic reactions can range from mild to moderate, including hives and swelling, to severe and life-threatening, such as anaphylaxis. More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year.

This marks the fourth FDA-approved indication for Xolair across allergic and inflammatory conditions, including moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). Since its initial approval in 2003, more than 700,000 patients have been treated with Xolair in the U.S.

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. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is available at 866-4ACCESS/866-422-2377.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

About the OUtMATCH Study

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.

The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is being conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10 clinical sites across the U.S. led by Johns Hopkins Children's Center and co-led by Stanford School of Medicine. The study is also supported by Genentech and Novartis Pharmaceuticals Corporation.

About Xolair

In the U.S., 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

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:


XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. XOLAIR should also not be used to treat other forms of hives, or sudden breathing problems.

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:

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.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions,

including if you:

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?

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

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.

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide for additional Important Safety Information and Instructions for Use, or visit https://www.Xolair.com.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Source: Genentech

Posted: February 2024

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