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Roche, Novartis food allergy drug Xolair gets US FDA breakthrough status


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Roche, Novartis food allergy drug Xolair gets US FDA breakthrough status

Roche Holding AG and Novartis AG's food allergy drug Xolair received breakthrough therapy status from the U.S. Food and Drug Administration.

Xolair, also known as omalizumab, is used to prevent severe allergic reactions due to accidental exposure to certain foods.

Breakthrough status is an expedited review process for drugs that treat serious or life-threatening diseases.

The designation was based on data from seven clinical studies conducted over a decade which evaluated Xolair's safety and effectiveness against food allergens including peanut, milk and egg.

Xolair is jointly developed and promoted by Switzerland-based Novartis and Roche's Genentech Inc. unit. The companies are planning to start a study of Xolair in multiple food allergies, and will disclose details later.

Genentech said up to 8% of children and 4% of adults in the U.S. are affected by food allergies, which cause an estimated 200,000 emergency room visits annually.

Food allergies are a growing public health concern for which there are currently no FDA-approved treatments," Sandra Horning, Genentech's chief medical officer and head of global product development, said in a news release.

Xolair is already approved to treat certain patients with asthma and chronic idiopathic urticaria, also known as hives. The drug is also approved in China for treating moderate to severe persistent allergic asthma.