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| |  FDA Assigns Priority Review Status to Enbrel (Etanercept) Application For Psoriatic Arthritis SEATTLE, WA -- September 17, 2001 -- Immunex Corporation and Wyeth-Ayerst Laboratories, a division of American Home Products, announced today that the U.S. Food and Drug Administration (FDA) granted priority review status for Immunex's supplemental Biologics License Application (sBLA) to use Enbrel® (etanercept) in the treatment of psoriatic arthritis. Enbrel is the first product ever reviewed by the FDA to treat the signs and symptoms of psoriatic arthritis. The FDA notified Immunex in writing today that the sBLA for Enbrel was accepted for filing. Separate from the letter of notification, the FDA has confirmed that the agency has assigned the Enbrel sBLA a priority review status. Priority review status indicates that the FDA is to act on the Enbrel sBLA within six months of submission date. Immunex submitted its sBLA for Enbrel on July 16, 2001. "We look forward to working with the FDA to expeditiously complete the review process for Enbrel in the treatment of psoriatic arthritis," said Leslie Garrison, senior vice president of clinical research and development at Immunex. "Because this patient population of 300,000 people has yet to see an FDA-approved treatment for psoriatic arthritis, we are pleased to be moving forward with the review process under priority review status." Acceptance of the sBLA filing does not indicate that a license has been or will be issued nor does it represent any evaluation of the adequacy of the data submitted. Like rheumatoid arthritis (RA), psoriatic arthritis is a chronic inflammatory disease of the joints and connective tissue. The disease causes joint pain and swelling that can lead to crippling and, unlike RA, also causes inflamed and irritated scaly red patches of skin throughout the body. It is a progressive and debilitating disease and because there are no treatments specifically approved for psoriatic arthritis, doctors often use therapies approved for RA, including non-steroidal anti-inflammatory drugs (NSAIDs) and disease modifying anti-rheumatic drugs (DMARDs). There are approximately 300,000 patients with psoriatic arthritis in the United States, and the disease affects both men and women usually between the ages 30 and 50. Psoriatic arthritis patients are generally treated by rheumatologists and dermatologists. An application for marketing approval of Enbrel was fast-tracked by the FDA in 1998. Six months after the application was submitted, the FDA approved Enbrel for reducing the signs and symptoms of moderately to severely active RA in patients who have had an inadequate response to one or more DMARDs. The following year, the FDA approved Enbrel for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs. In June 2000, the FDA approved Enbrel for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active RA. Enbrel is the only TNF inhibitor approved for use as a first-line therapy for RA. Enbrel acts by binding TNF, one of the dominant cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that cause the inflammatory process of RA and psoriatic arthritis. Enbrel competitively inhibits binding of TNF molecules to the TNF receptor sites. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. SOURCE: Immunex Corporation Related Links: Enbrel (etanercept), Immunex Corporation and Wyeth-Ayerst Laboratories.
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