ARTICLE | Company News

J&J gets CRL for sirukumab in RA

September 22, 2017 10:45 PM UTC

Johnson & Johnson (NYSE:JNJ) said FDA issued a complete response letter to a BLA for sirukumab (CNTO 136) to treat moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).

J&J said FDA requested additional clinical safety data, but declined to say whether it would need to conduct an additional trial. The pharma said it is reviewing the letter and plans to discuss next steps with FDA...

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