BioCentury
ARTICLE | Company News

GSK submits sirukumab MAA

September 12, 2016 7:00 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) announced the submission of an MAA to EMA for sirukumab ( CNTO 136) to treat moderately to severely active rheumatoid arthritis. GSK and partner Johnson & Johnson (NYSE:JNJ) are seeking sirukumab's approval in combination with methotrexate in adults who have failed or are intolerant to conventional or biologic disease-modifying anti-rheumatic drugs (DMARDs), and as monotherapy in adults for whom treatment with methotrexate is inappropriate.

The therapy is a human IgG1 kappa mAb against interleukin-6 (IL-6). In December 2015, GSK said sirukumab produced positive top-line results in three Phase III studies, but did not disclose details. It reported more detailed data from one of the studies in June (see BioCentury Extra, June 8). ...