Amgen seeks Enbrel approval for psoriasis

Amgen, which manufacturers much of its Enbrel supply in West Greenwich, announced earlier this year that psoriasis patients in late-stage clinical trials showed significant improvement when treated with the rheumatoid arthritis drug.

The Thousand Oaks, Calif. company said in a press release that it would not predict how long the U.S. Food & Drug Administration would take to rule on the application.

Approval would open the door to a new, large market for Enbrel. Psoriasis, an inflammatory skin condition, inflicts an estimated 7 million Americans. Analysts estimate the market for psoriasis biological drugs could be worth $2 billion by 2007, according to Biotech Week, a trade publication.

The FDA recently approved a new psoriasis drug developed by Cambridge-based Biogen Inc. called Amevive. Johnson & Johnson, Abbot Laboratories and Genentech Inc. all have psoriasis drugs in development.

Aside from rheumatoid arthritis, Enbrel also is approved for juvenile rheumatoid arthritis and psoriatic arthritis. It also is under review as a treatment for ankylosing spondylitis, an inflammatory disease of the spine.

Enbrel is considered the most successful biotechnology drug ever made, with expected 2003 revenue of between $1.2 billion and $1.4 billion. It has been used to treat more than 180,000 patients since the FDA approved the injectible medication five years ago.

During much of that time though, Amgen’s predecessor, Immunex, which Amgen acquired in 2002, struggled to meet demand for the drug, and a waiting list for the medication grew to more than 40,000.

Amgen’s West Greenwich plant, which began producing commercial Enbrel in January, helped wipe out that waiting list. The company is spending $500 million to build another production facility next door that should be completed in 2005.