Janssen receives FDA Complete Response letter for SIMPONI sBLA to treat RA

Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its supplemental Biologics License Application (sBLA) for SIMPONI® (golimumab).  The application, filed in September 2010, seeks to expand the SIMPONI® physician label to include inhibiting the progression of structural damage, inducing major clinical response (MCR) and maintenance of reduction of signs and symptoms and maintenance of improved physical function in the treatment of moderately to severely active rheumatoid arthritis (RA).  

Janssen Biotech, Inc. intends to request an end-of-review meeting with the FDA to thoroughly understand the details of the Complete Response letter and discuss future steps to achieve the intended approval.

"SIMPONI® is an important once-monthly anti-tumor necrosis factor (TNF)-alpha therapy for rheumatologists in the treatment of patients with moderately to severely active rheumatoid arthritis," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Centocor Research & Development division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  "We look forward to collaborating with the FDA to fully understand the requirements needed to support this proposed label expansion."

In 2009, SIMPONI® received approvals in the United States, Europe and Canada for the treatment of moderately to severely active RA in combination with methotrexate, active psoriatic arthritis and active ankylosing spondylitis as a once-monthly subcutaneously administered treatment.  

In January 2011 the European Commission approved SIMPONI® in combination with methotrexate for the treatment of adults with severe, active and progressive RA not previously treated with methotrexate, and for the reduction in the rate of progression of joint damage as measured by X-ray in patients with RA.  On July 1, SIMPONI® received approval in Japan for the treatment of RA including prevention of articular structural damage in patients who showed inadequate response to conventional therapies.

SOURCE Janssen Biotech, Inc.


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