New Rheumatoid Arthritis Drug Earns FDA Approval

A drug to be taken by adults with moderate-to-severe rheumatoid arthritis and similar disorders has earned approval by the Food and Drug Administration.

Simponi, made by Centocor Ortho Biotech Inc., of Malvern, Pa., is the brand name of the drug golimumab. It is injected under the skin once a month and meant to be used along with the immunosuppressant drug methotrexate.

The drug also is approved for treatment of active psoriatic arthritis and active ankylosing spondylitis, two other chronic disorders which cause the body’s immune system to attack joints, resulting in pain, stiffness, and difficulty moving.

“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. “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.”

Class of Protein-Blocking Drugs

Simponi drug belongs to a class of drugs called TNF-α blockers, which target a specific protein that can cause inflammation and damage to bones, tissue, and cartilage when there is too much of it in the body.

The drug performed well in clinical trials of the drug in treating all three chronic conditions. It was proven to reduce the signs and symptoms caused by the various forms of arthritis, officials said. However, Simponi does carry some risk of serious side effects, the FDA warned.

Side Effects and Warnings

Just like other drugs in the same class, Simponi’s package labeling will carry a prominent warning about the risk of developing tuberculosis and invasive fungal infections. The drug will also carry a Medication Guide to further warn users about the risks of the drug.

Common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion, the FDA said.

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