Novartis: FDA Accepts Xolair sBLA for Nasal Polyps
December 11 2019 - 6:37AM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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