23 September 2016 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Data from the Phase 3 SIRROUND clinical development program, which includes five studies (SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M and SIRROUND-LTE) served as the basis for submission. Results from the SIRROUND-D study were recently presented at the Annual European Congress of Rheumatology (EULAR 2016), and results from the SIRROUND-T and SIRROUND-H studies are planned for presentation later this year.

Read Janssen press release