Roche: FDA grants breakthrough therapy designation to Xolair
(CercleFinance.com) - Genentech, a unit of Swiss drugmaker Roche, said on Monday that it has been granted breakthrough therapy designation by the US Food and Drug Administration for its food allergy treatment Xolair.
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 approval and review of medicines intended to treat serious or life-threatening diseases.
The FDA has made its decision based on data from seven clinical studies over the last decade which assessed the efficacy of Xolair against food allergens such as peanuts, milk, eggs and others.
Up to 8% of children and 4% of adults are affected by food allergies in the US, Genentech said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
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 approval and review of medicines intended to treat serious or life-threatening diseases.
The FDA has made its decision based on data from seven clinical studies over the last decade which assessed the efficacy of Xolair against food allergens such as peanuts, milk, eggs and others.
Up to 8% of children and 4% of adults are affected by food allergies in the US, Genentech said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.