Genentech announces FDA Breakthrough Therapy Designation granted for Xolair

Genentech, a member of the Roche Group (RHHBY), announced that the FDA has granted Breakthrough Therapy Designation for Xolair 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. Genentech and Novartis Pharmaceuticals are working closely with NIAID and the Consortium of Food Allergy Research, or 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 Pharmaceuticals 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 is an affiliate of Novartis (NVS).

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