SEATTLE, WA Immunex Corporation (Nasdaq: IMNX) and Wyeth-Ayerst Laboratories, a division of American Home Products (NYSE: AHP) announced today that the U.S. Food and Drug Administration (FDA) has approved ENBREL (etanercept) to treat people with psoriatic arthritis. ENBREL is the first therapy to receive approval to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. ENBREL can be used without methotrexate. ENBREL can also be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Psoriatic arthritis is an often painful chronic inflammatory disease characterized by both joint and skin manifestations.
Unlike other types of arthritis, people with psoriatic arthritis often experience progressive joint pain and swelling, coupled with scaly red skin lesions, said Gail Zimmerman, president and CEO, National Psoriasis Foundation. There is a definite need for new approved therapies to specifically treat this disease. Current therapies for psoriatic arthritis have been borrowed from other diseases and do not work for everyone.
Because this disease typically begins with skin plaque symptoms and then progresses to joint involvement, physicians have faced special diagnostic challenges in identifying patients with psoriatic arthritis.
As a dermatologist, I have seen many psoriatic arthritis patients who have received conflicting diagnoses, said Kenneth Gordon, MD, Department of Dermatology, Northwestern University. Now that there is an approved therapy for this disease, my hope is that this approval heightens physicians and the publics awareness of the symptoms of psoriatic arthritis, which may lead to quicker and more accurate diagnoses, thus more effective treatment.
A supplemental Biologics License Application (sBLA) was submitted for use of ENBREL (etanercept) in psoriatic arthritis on July 16, 2001. In September, the FDA granted priority r
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Contact: Aimee Jobe
aimee_jobe@chi.bm.com
312-596-3411
Burson-Marsteller
16-Jan-2002
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