Janssen submits sirukumab BLA

The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) submitted a BLA to FDA for sirukumab ( CNTO 136) to treat moderately to severely active rheumatoid arthritis in adults who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).

An MAA for the human IgG1 kappa mAb against interleukin-6 (IL-6) was submitted to EMA earlier this month (see BioCentury Extra, Sept. 12). ...