Novartis, Roche's Food Allergies Treatment Xolair Gets FDA Approval

By Sabela Ojea

Novartis and Roche Holding said the U.S. Food and Drug Administration approved their Xolair treatment to reduce allergic reactions following the exposure to one or more foods.

The pharmaceutical companies on Friday said Xolair has been approved for patients aged one year and older with the IgE-mediated food allergy.

Patients taking Xolair for food allergies should continue to avoid all foods they are allergic to, the companies added.

Xolair, a prescription biologic medicine that is given as an injection, shouldn't be taken as an emergency treatment for allergic reactions.

The FDA approval is based on positive data from the Phase 3 OUtMATCH study, which evaluated Xolair in patients aged 1 to 55 allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut.

In the U.S., Novartis Pharmaceuticals and Genentech, a member of the Roche Group, develop and co-promote Xolair.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

February 16, 2024 12:03 ET (17:03 GMT)

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