Amgen has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for the use of Enbrel (etanercept) to improve physical function in patients with moderately to severely active rheumatoid arthritis. Approval of the submission would further expand the broad label currently approved for Enbrel.

"The data we are submitting to the FDA demonstrate that patients treated with Enbrel showed an improvement in physical functioning," said Daniel Burge, Amgen vice president of clinical research. "We frequently hear from patients that they''ve been able to resume many of their daily activities, such as brushing their hair or picking up their child, that had become impossible due to their rheumatoid arthritis."

Enbrel is approved to reduce the signs and symptoms in patients with moderately to severely active RA who have had an inadequate response to at least one disease modifying antirheumatic drug (DMARD), such as methotrexate. 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 alone 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.

Enbrel is the only fully-human anti-TNF therapy approved for use without methotrexate, a drug that has been the most commonly used disease modifying drug for RA. Enbrel is also the only TNF receptor on the market. It acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process of RA and psoriatic arthritis. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.

Enbrel is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis; reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients 4 years of age and older who have had an inadequate response to one or more DMARDs; and reducing signs and symptoms of active arthritis in patients with psoriatic arthritis.