Roche Gets U.S. Approval for Food Allergy Drug

By Andrea Figueras

Roche Holding said that the U.S. Food and Drug Administration has approved Xolair, the first medicine for children and adults to reduce allergic reactions to multiple foods.

The FDA approval is based on positive data from a study which evaluated the drug in patients aged one to 55 years, the Swiss pharmaceutical company said Friday.

Data from the study showed that a significantly higher proportion of food-allergy patients treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared with those treated only with a placebo, the company said.

"People taking Xolair for food allergies should continue to avoid all foods they are allergic to," Roche said, noting that the drug is intended to reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure to those foods, but should not be used for emergency treatment resulting from any allergic reaction.

The drug is widely available and can now be prescribed in the U.S., Roche said.

Write to Andrea Figueras at andrea.figueras@wsj.com

(END) Dow Jones Newswires

February 16, 2024 12:13 ET (17:13 GMT)

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