Federal regulators approved golimumab (Simponi), a new biologic drug to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, conditions where the immune system attacks the joints causing pain, stiffness and restricted motion.
In announcing the approval of golimumab, a once-monthly, under-the-skin injection, Food and Drug Administration officials noted that the new drug was intended to be used in combination with methotrexate for cases of moderate-to-severe rheumatoid arthritis and alone or in combination with methotrexate for cases of active psoriatic arthritis or active ankylosing spondylitis.
Golimumab belongs to a class of medications that block tumor necrosis factor-alpha, or TNF-a, a chemical signal for inflammation. Like similar medications, golimumab will carry a boxed warning about the increased risks of tuberculosis and invasive fungal infections associated with its use.
In a press statement, Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation said that approval of golimumab offered another treatment option to people who live with “these three debilitating disorders.”
“And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class," Dr. Rappaport said.
In clinical trials, the most common side effects reported with the use of golimumab included respiratory infection, sore throat and nasal congestion.
The SmartJect Autoinjector, a more patient-friendly take on the classic syringe, which will be sold along with the drug, has received the Arthritis Foundation's Ease-of-Use Commendation.