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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