Sunday, Aug 12, 2018
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
South San Francisco, CA -- August 12, 2018 --
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.
Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat:
Important Safety Information
The most important information patients should know about XOLAIR is that a severe allergic reaction called anaphylaxis can happen when a patient receives 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. Patients must go to the nearest emergency room right away if they have any of these symptoms of an allergic reaction:
The patient’s healthcare provider will monitor the patient closely for symptoms of an allergic reaction while they are receiving Xolair and for a period of time after the patient’s injection. The patient’s healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
Patients must not receive Xolair if they are allergic to omalizumab or any of the ingredients in Xolair.
Before receiving Xolair, patients must tell their healthcare provider about all of their medical conditions, including if they:
Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins or herbal supplements.
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. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. 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 at http://www.xolair.com for additional Important Safety Information.
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.
# # #