AHP, Immunex Get FDA Approval to Market Enbrel for Psoriatic Arthritis

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AHP, Immunex Get FDA Approval to Market Enbrel for Psoriatic Arthritis

WASHINGTON (Reuters Health) Jan 16 - American Home Products Corp. subsidiary

Wyeth-Ayerst Laboratories and Immunex Corporation jointly said on Wednesday that

they have received a supplementary approval from the US Food and Drug

Administration (FDA) to market the arthritis therapy Enbrel (etanercept) for the

treatment of psoriatic arthritis.

Enbrel was first approved in 1998 for the treatment of rheumatoid arthritis

(RA). The supplementary application for psoriatic arthritis was filed in July

and was subsequently granted priority review by the FDA in August.

Roughly 1 million US adults have psoriatic arthritis, a number significantly

higher than previously believed, according to research released Wednesday by the

National Psoriasis Foundation (NPF).

The companies said that the supplementary FDA approval was based on 24-week-long

phase III study involving 205 patients with psoriasis. Results of the study were

first released in November at a meeting of the American College of Rheumatology

in San Francisco. According to researchers, after 24 weeks about 59% of patients

taking Enbrel had significant improvement in the signs and symptoms of the

disease compared with 15% of those on placebo.