Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis

Janssen Biotech has announced the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory condition that affects approximately 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, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “We are pleased to submit an application for sirukumab to the U.S. 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 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.

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