CRL for Janssen's rheumatoid arthritis drug BLA

The US Food and Drug Administration has issued a complete response letter (CRL) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA).

The CRL, issued to Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA. The decision follows a negative FDA arthritis advisory panel meeting in August, which voted to not approve sirukumab. News of the FDA announcement had almost no impact on J&J’s shares.

Analysts on average had expected sirukumab, which would carry the trade name Plivensia if ultimately approved, to generate annual global sales of $426 million by 2020, according to Reuters.