FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies

Kids With Food Allergies is sharing this press release from Genetech to bring you the latest research news quickly.


[PRESS RELEASE]

FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies

– There are currently no FDA-approved treatments that help prevent severe reactions due to food allergies –

– As many as 15 million Americans have food allergies – including approximately 6 million children – and the incidence is increasing –

August 13, 2018 -- SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval as soon as possible. This is the 23rd Breakthrough Therapy Designation for Genentech’s portfolio of medicines.

“Food allergies can have a significant impact on the lives of children and adults, and they are a growing public health concern for which there are currently no FDA-approved treatments,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening.”

Food allergies can be life-threatening, and result in an estimated 200,000 emergency room visits each year. Up to 8 percent of children and 4 percent of adults in the U.S. are affected by food allergies, and the incidence is increasing.

Breakthrough Therapy Designation was granted on the basis of data from seven clinical studies over the last decade assessing the efficacy and safety of Xolair against a range of food allergens including peanut, milk, egg and others. These studies of Xolair, as monotherapy or in combination with oral immunotherapy (OIT), were supported by Genentech and independent sponsors including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Genentech and Novartis Pharmaceuticals Corporation are working closely with NIAID and the Consortium of Food Allergy Research (CoFAR) to initiate a potentially pivotal study evaluating the efficacy and safety of Xolair in multiple food allergies and will disclose details at a later date.

In the U.S., Genentech, Inc. and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. Genentech is a leading biotechnology company that discovers, develops, manufacturers and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies.

About Xolair

Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat:

Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens.

Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.

Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

Please see full Prescribing Information, including Medication Guide at http://www.xolair.com/ for additional Important Safety Information.

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 or 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.

Contacts

Genentech
Media Contact:
Heather Gloe, 650-467-6800

Advocacy Contact:
Jocelyn Ashford, 650-866-7579

Investor Contact:
Loren Kalm, 650-225-3217
Karl Mahler, 011 41 61 687 8503

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Comments (6)

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So I believe this approval means it can be used in general as a protection against anaphylaxsis from food on its own and then also in conjunction w/ OIT.  Anyone know if there is still a 6 year old age minimum?  looking/googling

Hugs, Michele! Your story is a great reminder that we are all unique, and each medication has its own risks and benefits that can differ from patient to patient.

So glad she's doing better now, and I know the reaction had to be plenty scary!

To follow:  for allergies she is on Zyrtec, budesonide nasal, pazeo, eucrisa, various topical steroids, dulera, spiriva, and prn duoneb, Benadryl, hydtoxyzine, epinephrine.  Has hashimotos and iatrogenic adrenal insufficiency too.  Plus pots and migraines.  So, other meds for those.  

Hi; DD is fragile atopic; the idiopathic uticatia dx was used to fast track xolair approval.  Long story, involving immune dysfunction and NIH, but she’s on cell cept now and feeling better.  That would not typically be a path for a fa kid.  

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