Novartis, Genentech: FDA to Review Xolair Self-Administration Option

By Colin Kellaher

Novartis AG and Roche Holding AG's Genentech unit on Thursday said the U.S. Food and Drug Administration accepted their application for a self-administration option for the asthma and allergy drug Xolair.

The companies said they expect a decision by the first quarter of 2021, adding that approval would make Xolair prefilled syringes available for either self-administration by select patients or administration by their caregivers.

Xolair is currently approved in the U.S. for administration by a healthcare provider in a healthcare setting for patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria, or hives.

Genentech said the Covid-19 pandemic has created an urgent need for the Xolair self-administration option, particularly for patients considered high-risk for severe illness.

Novartis and Genentech, which develop and co-promote Xolair in the U.S., said about 460,000 patients have been treated with the drug in the country since its initial approval for allergic asthma in 2003.

The European Commission approved Xolair self-administration in December 2018.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 13, 2020 09:49 ET (13:49 GMT)

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