FDA Grants Breakthrough Therapy Designation for Xolair

Genentech announced 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.

"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 eight percent of children and four 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 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 and Novartis worked together to develop and co-promote Xolair.

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