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ENBREL Is First Anti-TNF Therapy Submitted To the FDA for Approval to Treat Psoriasis.

Article Excerpt
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., July 8 /PRNewswire/ -- Amgen and Wyeth Pharmaceuticals, a division of Wyeth , today announced a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ENBREL(R) (etanercept) to treat moderate to severe plaque psoriasis. Psoriasis is an inflammatory disease affecting nearly seven million people in the United States and is characterized by chronic inflammation of the skin.

"We are pleased to have submitted an application for the first therapy that targets Tumor Necrosis Factor (TNF), the dominant inflammatory cytokine in psoriasis," said Dr. Beth Seidenberg, Amgen's senior vice president of development. "In the clinical studies, many patients treated with ENBREL experienced significant improvement in their symptoms."

Results of the Phase 3 trials were reported in March at the American Academy of Dermatology annual meeting and in June at the International Psoriasis Symposium.

"ENBREL is well studied with nearly five years of post-marketing experience across approved indications and has an established tolerability profile which we know is important to the dermatology community," said Dr. Alice Gottlieb, professor of medicine at the University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School.

Adverse events were similar to those reported in previous clinical trials of ENBREL in patients with RA.

"ENBREL has been studied in nearly 1,200 psoriasis patients participating in the pivotal trials," said Dr. Victoria Kusiak,...