LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) said that a Biologics License Application or BLA has been submitted by Janssen Biotech, Inc., (JBI) to the U.S. Food and Drug Administration or FDA, seeking approval of a subcutaneous formulation of sirukumab.
Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody 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 or DMARDs.
Sirukumab is being co-developed for rheumatoid arthritis or RA as part of a collaboration with Janssen Biologics (Ireland), an affiliate of JBI.
Approval is being sought for the subcutaneous formulation of sirukumab in two presentations, a single-dose prefilled syringe and a single-dose autoinjector. The data to support the file are based on a comprehensive phase III clinical development programme involving more than 3,000 patients.
A regulatory submission to the European Medicines Agency or EMA was announced on 12 September 2016. Sirukumab is currently not approved as a treatment for any indication anywhere in the world.
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