Roche's Xolair Granted FDA Priority Review

By Mauro Orru

Roche Holding's Xolair antibody received priority review treatment from the Food and Drug Administration after a late-stage study yielded positive results that the company said could make Xolair the first medicine to reduce allergic reactions to multiple foods.

The Swiss pharmaceutical company said Tuesday that the FDA should make a decision on approval in the first quarter of the new year, after positive results from a phase 3 study assessing Xolair in patients allergic to peanuts and at least two other common foods.

"Despite the significant and growing health burden from food allergies, treatment advances have been limited," said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development. "The FDA's priority review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S."

Write to Mauro Orru at mauro.orru@wsj.com

(END) Dow Jones Newswires

December 19, 2023 10:12 ET (15:12 GMT)

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