GlaxoSmithKline Files US Regulatory Application for Sirukumab in Rheumatoid Arthritis
September 23 2016 - 08:35AM
Dow Jones News
LONDON--GlaxoSmithKline PLC (GSK.LN) said Friday it has filed a
U.S. regulatory submission for sirukumab in rheumatoid
arthritis.
The pharmaceutical giant has submitted a biologics license
application to the U.S. Food and Drug Administration by Janssen
Biotech, Inc., seeking approval of a subcutaneous formulation of
sirukumab for the treatment of adult patients with moderately to
severely active rheumatoid arthritis who have failed, or are
intolerant to one or more disease-modifying antirheumatic
drugs.
Sirukumab is being co-developed for rheumatoid arthritis as part
of a collaboration with Janssen Biologics (Ireland), an affiliate
of JBI.
A regulatory submission to the European Medicines Agency was
announced on Sept. 12. Sirukumab is currently not approved as a
treatment for any indication anywhere in the world.
Shares at 1205 GMT down 0.5 pence, or 0.03%, at 1648.5
pence.
-Write to Ian Walker at ian.walker@wsj.com; @IanWalk40289749
(END) Dow Jones Newswires
September 23, 2016 08:20 ET (12:20 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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