CNTO 136 (sirukumab) filed with FDA for rheumatoid arthritis - Janssen
Janssen Biotech announced the submission of a Biologics License Application (BLA) to the FDA seeking approval of CNTO 136 (sirukumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
Data from the Phase III SIRROUND clinical development program, which includes five studies (SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M and SIRROUND-LTE) served as the basis for submission. Results from the SIRROUND-D study were recently presented at the Annual European Congress of Rheumatology (EULAR 2016), and results from the SIRROUND-T and SIRROUND-H studies are planned for presentation later this year.
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