Janssen files BLA for US approval of sirukumab for rheumatoid arthritis

Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), says it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis. RA is a chronic, systemic inflammatory condition that affects around 1.5 million Americans.

“We are committed to deepening our understanding of rheumatoid arthritis with the goal of applying new scientific learnings to advance treatments like sirukumab for people living with this inflammatory rheumatologic disease,” said Newman Yeilding, head of immunology development at Janssen Research & Development, adding: “We are pleased to submit an application for sirukumab to the US Food and Drug Administration and look forward to working with the agency with the goal of bringing this new biologic therapy to patients in need of alternative treatment options.”

Data from the Phase III 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.