Centocor Requests FDA Approval Of Golimumab | Arthritis Information

 

Centocor, Inc. Submits Application To FDA Requesting Approval Of Golimumab For The Treatment Of Rheumatoid Arthritis:

Centocor, Inc. announced that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and is also being studied as an intravenous (IV) infusion therapy. In February 2008, Centocor submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for the same indications.

"This submission marks a major milestone in the clinical development program of golimumab, and we look forward to working with the FDA to bring golimumab to market," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "We remain focused on our commitment to innovation in the field of biomedicines, to addressing the ongoing needs of patients living with these debilitating diseases and to physicians in need of additional therapeutic options to effectively treat their patients."

Five pivotal Phase 3 trials support the BLA, which include the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study; the GOlimumab FOR subjects With Active RA Despite MTX (GO-FORWARD) study; and A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Human Anti-TNF-alpha Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNF-alpha Agent(s) (GO-AFTER) study were recently presented at the European League Against Rheumatism Annual Congress. In November 2007, primary endpoint study findings from the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial were reported at the American College of Rheumatology Annual Scientific Meeting.

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