FDA expands psoriatic arthritis indication for Enbrel
Posted June 8, 2005
On June 1, 2005, Amgen & Wyeth announced that the U.S. Food and Drug Administration approved the use of Enbrel (generic name etanercept) to improve physical function for people with psoriatic arthritis. The decision allows the companies to market Enbrel for improvement of physical function in patients with psoriatic arthritis in addition to the previously approved treatment for signs and conditions of the disease.
The label has also been updated to include data showing that Enbrel reduced the progression of joint damage for two years among most psoriatic arthritis patients using the treatment.
Enbrel was approved for treatment of psoriatic arthritis in January 2002, and in April 2004 for psoriasis. It is also approved for treating rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis (arthritis affecting the spine). The updated indication was based on a study showing that 40 percent of the patients improved in their ability to perform daily activities, such as dressing, walking and grooming.
For more information about administration, side effects or cost, please visit the Enbrel fact sheet.
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