WASHINGTON, April 24 — The FDA has approved the monoclonal antibody golimumab (Simponi) as a once a month treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

The agency said the drug is intended for use in combination with methotrexate in patients with rheumatoid arthritis.

It can be used with or without methotrexate in psoriatic arthritis patients, and as monotherapy in patients with ankylosing spondylitis.

“Today’s approval provides another treatment option for patients with these three debilitating disorders,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

Noting that there have been some concerns about safety with this class of drugs, Dr. Rappaport said the FDA was taking steps to “minimize the risks so patients will have the same level of safety protection required for other drugs in its class.”

The monthly subcutaneous injection will include a boxed warning typical of all tumor necrosis factor-alpha blockers about an associated risk of tuberculosis and invasive fungal infection.

The FDA also required a risk evaluation mitigation strategy (REMS) for golimumab, as it required for other TNF-? blockers. The REMS for Simponi includes a medication guide for patients and a communication plan to help physicians understand the drug’s risks.

In clinical trials, the most common adverse reactions to golimumab included upper respiratory tract infection, sore throat and nasal congestion.

Golimumab is marketed by Centocor Ortho Biotech., Malvern, Pa.

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