Amgen has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) to further expand the use of Enbrel (etanercept) to inhibit the progression of structural damage in psoriatic arthritis patients. Enbrel is the first and only approved therapy to treat active arthritis in patients with psoriatic arthritis and has been shown to improve the psoriatic skin lesions associated with the disease.

"In clinical trials, patients with psoriatic arthritis taking Enbrel showed a significant improvement in each area of measurement related to bone and joint damage, including total Sharp score, joint erosion score and joint space narrowing," said Daniel Burge, Amgen vice president of clinical research. "We're encouraged by the magnitude of improvement produced by treatment with Enbrel for 12 months."

The sBLA is based on the results of a 12-month, double blind, placebo controlled trial. The study results will be presented in a plenary session at the 66th Annual American College of Rheumatology Scientific Meeting in New Orleans.

Also under review is an sBLA recently filed by Amgen for the use of Enbrel to improve physical function in patients with rheumatoid arthritis (RA). Enbrel has the broadest range of indications of any biologic therapy in rheumatic diseases. It is currently approved to reduce the signs and symptoms in patients with moderately to severely active RA. It is also indicated to inhibit the progression of bone and joint damage in patients with moderately to severely active RA. Additionally, Enbrel is the only anti-TNF therapy approved:
* To be used without methotrexate to treat patients with moderately to severely active RA;

* To treat patients 4 years of age and older with moderately to severely active polyarticular-course juvenile rheumatoid arthritis who have had an inadequate response to DMARDs

* To treat newly diagnosed RA patients with moderately to severely active disease; and

* To treat active arthritis in patients with psoriatic arthritis.

Approved since 1998, Enbrel has been used to treat more than 129,000 patients.

Psoriatic arthritis is a distinct, chronic inflammatory disease of the joints and connective tissue. The disease combines joint pain and swelling that can lead to crippling debilitation, with psoriasis, an inflammatory skin disorder characterized by frequent episodes of redness and itching; thick, dry, silvery scales on the skin; and nail abnormalities. There are approximately 450,000 patients with psoriatic arthritis in the United States and the disease affects both men and women most commonly between the ages 30 and 50.

Enbrel is the only fully human TNF receptor approved for use to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active RA. Enbrel is the only biologic therapy approved to treat newly diagnosed RA patients with moderately to severely active disease, and can be used alone.