Posted by Michael Wonder on 23 Sep 2017
Janssen receives complete response letter from U.S. FDA for sirukumab biologics license application
22 September 2017 - Janssen Biotech announced today that it has received a complete response letter from the U.S. FDA for the Biologics License Application seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis.
The complete response letter indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active rheumatoid arthritis (RA).
On August 2, 2017, the FDA’s Arthritis Advisory Committee did not recommend approval of sirukumab for RA. Convened upon the request of the FDA, the committee reviews and evaluates safety and efficacy data of human products for use in the treatment of arthritis. The committee provides non-binding recommendations based on its evaluation; however, the FDA makes the final decision on approval of the drug.
