By SPC News Staff
The FDA declined to approve sirukumab (Janssen Biotech), until the company provides more safety data.
In its complete response letter to the biologics license application (BLA) for sirukumab (proposed brand name, Plivensia) for the treatment of moderately to severely active rheumatoid arthritis (RA), the FDA said additional clinical data are needed to further evaluate the safety of the product for this indication.