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Genentech's Xolair Receives FDA's Breakthrough Therapy Designation for Food Allergies

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Genentech's Xolair Receives FDA's Breakthrough Therapy Designation for Food Allergies

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  •  The BT designation is based on seven clinical studies evaluating safety and efficacy for allergens including peanut- milk- egg and others
  • The BT designation for Xolair (omalizumab) is to prevent severe allergic reactions following accidental exposure to one or more foods in people with allergies
  • Genentech and Novartis are working with NIAID and the Consortium of Food Allergy Research (CoFAR) initiating a pivotal study for evaluating the efficacy and safety of Xolair in multiple food allergies. Additionally- Genentech and Novartis are working to co-develop and co-promote Xolair

/ article | Ref: Roche | Image: Forbes


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