Janssen submits application for FDA approval of sirukumab for RA
Janssen Biotech Inc. announced it has submitted a biologics license application to the FDA for approval of sirukumab to treat adults with moderate to severe rheumatoid arthritis.
“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,” Newman Yeilding, MD, head of Immunology Development, Janssen Research and Development LLC, said in a press release. “We are pleased to submit an application for sirukumab to the U.S. FDA 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.”
According to the release, the basis of the submission was data from the 3 SIRROUND clinical development program.