Golimumab application filed with the FDA
On June 27, Centocor, Inc. filed an application with the U.S. Food and Drug Administration (FDA) requesting approval for golimumab, a treatment for adults living with psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis.
Golimumab is a human monoclonal antibody that targets and inactivates tumor necrosis factor alpha—a signaling protein that plays an important role in many immune-mediated diseases, including psoriatic arthritis.
"Since golimumab is a fully human protein, it is less likely to be neutralized by the patient's immune response," said Bruce Bebo, Jr., Ph.D, director of research for the National Psoriasis Foundation.
Five Phase 3 trials strongly support that using golimumab helps improve the signs and symptoms of arthritis, psoriatic arthritis and ankylosing spondylitis. In the studies, the drug was administered as a monthly injection.
"The FDA will review all of the efficacy and safety data and then determine whether the risks outweigh the benefits," said Bebo. "Based on the magnitude of the response reported in the recent clinical trials, I would not be surprised if the FDA votes to approve Centocor's application."
Earlier this year, Centocor filed an application with the European Medicines Agency requesting approval of golimumab to treat psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis in adult European patients.
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