FDA Approves Once Weekly Dose of Enbrel for Rheumatoid Arthritis

Patients taking Enbrel® (etanercept) for rheumatoid arthritis now have the convenience of taking a once weekly dose of the drug rather than twice weekly.

The U.S. Food and Drug Administration (FDA) recently approved the administration of Enbrel in a daily 50-milligram dose consisting of two injections. Previously, patients had to wait three or four days between injections.

The pivotal study leading to the FDA's approval of the new dose involved 420 rheumatoid arthritis patients who were treated with either once-weekly or twice weekly injections of Enbrel.

After eight and 16 weeks, the researchers found no significant differences in the improvement of the signs and symptoms of rheumatoid arthritis experienced by the patients. The ability of the participants to tolerate the once-weekly dose was comparable to that of twice-weekly dose.

The FDA's approval includes all of the indications for Enbrel.

Other sources: Amgen