The Food and Drug Administration on Friday approved rheumatoid arthritis drug golimumab marketed by Pennsylvania-based Centocor Ortho Biotech Inc., which will compete with Amgen Inc.’s Enbrel and Abbott Laboratories’ Humira.

 

Golimumab, to be sold under the brand name Simponi, was approved for use against ankylosing spondylitis, a progressive form of spinal arthritis and psoriatic arthritis, a form of arthritis often associated with the skin condition psoriasis.

 

The drug works by blocking TNF, or tumor necrosis factor, a germ-fighting protein that also can cause he inflammation found in rheumatoid arthritis patients.

 

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

 

Similar to other rheumatoid arthritis drugs, golimumab’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 its risks.

 

The most common side effects of Simponi include upper respiratory tract infection, sore throat and nasal congestion.