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FDA Grants Breakthrough Therapy Designation For Roche' Xolair For Food Allergies


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(RTTNews.com) - Genentech, a member of the Roche Group ( RHHBY ), said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for Xolair or 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 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.

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.


Read the original article on RTTNews (http://www.rttnews.com/2925891/fda-grants-breakthrough-therapy-designation-for-roche-xolair-for-food-allergies.aspx)


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This article appears in: World Markets , Stocks , Economy
Referenced Symbols: RHHBY



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