FDA Approves Sale of Humira for Rheumatoid Arthritis

The U.S. Food and Drug Administration has approved sale of Humira (adalimumab), a new drug for rheumatoid arthritis that may prove easier for patients to take than two older competitors.

Humira works by blocking an immune system protein called tumor necrosis factor, or TNF, that plays a key role in the pain and inflammation of rheumatoid arthritis.

Humira was specifically approved for reducing the signs and symptoms, and inhibiting the progression of structural damage, in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

While two other TNF blockers, Enbrel and Remicade, are already on the market, Humira requires an injection every other week while Enbrel requires two shots a week and Remicade is an intrevenous drug that requires an infusion in a doctor's office.

All three TNF blockers have similar side effects, including serious, sometimes fatal, infections.

Abbott Laboratories said it plans to begin the first shipments of Humira by mid-January with it available nationwide by the end of the month. The company said the drug's wholesale price will be identical to that of Enbrel.

Other sources: FDA, Abbott