Novartis: FDA Accepts Xolair sBLA for Nasal Polyps

By Colin Kellaher

Novartis AG (NOVN.EB, NVS) on Wednesday said the U.S. Food and Drug Administration accepted the company's supplemental biologics license application for Xolair for the treatment of nasal polyps in adults with inadequate response to intranasal corticosteroids.

The Swiss drug make said it expects the agency to make a decision on the indication by the third quarter of 2020.

Novartis said Xolair, if approved, would be the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E.

Xolair is currently approved in the U.S. to treat of moderate to severe persistent allergic asthma and chronic idiopathic urticaria. Novartis and Roche Holdings AG's (ROG.EB) Genentech unit work together to develop and co-promote Xolair in the U.S.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 11, 2019 06:22 ET (11:22 GMT)

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