News and Events News Archive

FDA panel recommends approval of new psoriasis drug

First posted May 24, 2002

An advisory committee to the U.S. Food and Drug Administration (FDA) voted May 23 to recommend approval of Biogen's drug alefacept (brand name Amevive) for the treatment of moderate to severe plaque psoriasis.

If the FDA goes along with the recommendation, Amevive will be available for patients by the beginning of 2003 at the latest, according to a spokesman for Biogen, the drug's manufacturer.

Lynn Drake, M.D., acting chairwoman of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC), prompted a vote with the question, "Has the sponsor shown that the product is safe and effective for the treatment of chronic plaque psoriasis?" Eight DODAC members voted "yes;" two said "no."

A majority of committee members said they were impressed with the effectiveness of Amevive in clinical trials, yet they also expressed anxiety over the lack of evidence on the drug's long-term safety. Several members suggested that the company establish a patient registry after the drug is approved to track all side effects reported by patients taking Amevive.

The two DODAC members who voted against recommending approval preferred that studies to answer safety questions be conducted prior to approving the drug. However, DODAC member J. Richard Taylor, M.D., a dermatologist and former member of the NPF Medical Advisory Board, suggested long-term data will be available from a large number of patients more quickly if those studies are conducted after the drug reaches the market. Compared to the treatments available now for the treatment of psoriasis, Amevive does looks safer, he added.

"This is at least equal, if not better, than most," Dr. Taylor said.

Biogen submitted Amevive to the FDA for approval in early August 2001, and the committee's recommendation should influence the agency's final decision on whether to approve the drug. The company will receive official notice from the FDA by Aug. 6, 2002, at the latest.

A majority of DODAC members agreed that the FDA should require Biogen to indicate on Amevive's label that the drug depletes immune system cells essential to fighting infections, and that patients should stop taking the medication if there is prolonged depletion of these cells (T cells).

Amevive is the first of a new class of drugs, called biologics, developed for psoriasis; it blocks a step in the underlying immune system process that drives the skin symptoms associated withthe disease.

The personal perspective on psoriasis
Gail M. Zimmerman, NPF president and CEO, and three NPF members testified before the committee about the need for new treatments for psoriasis and encouraged the committee to recommend approval of Amevive.

Diane Lewis, 33, an NPF member since 1986, described in compelling detail how severe psoriasis has impacted every aspect of her life, even her education. "I've had professors say to me, 'it's just a little skin thing,'" she said. "When I can't move and can't walk, it's not 'just a little skin thing.'"

Sean Morton, 28, said psoriasis brought down his self-esteem during the prime of his life. Before he developed psoriasis, Sean said he thought his self-esteem was unbreakable, but choosing clothes not because they look good but because they covered his lesions changed his mind. After participating in a clinical trial for Amevive, he said he got some of that self-esteem back.. "If you've lived like I have in the past two years, believe me, you would want this drug too," Mr. Morton said.

Since it was founded in 1968, the NPF has testified several times before the FDA to support the approval of new therapies for psoriasis. As an organization, the NPF does not recommend or endorse any particular treatment or product.

However, we do advocate to ensure that people with psoriasis and psoriatic arthritis have access to as many potentially safe and effective treatment options as possible. This is part of our mission of improving the quality of life of people who have these diseases.

The arrival of biologics
The NPF has been charting Amevive's progress through clinical trials, and recently launched a public education campaign called Step Into My Skin to inform people about new biologic therapies in development.

It is now widely accepted that psoriasis results from faulty reactions in the human immune system, which ultimately lead to accelerated growth of skin cells and the formation of the red, scaly lesions characteristic of the disease. "Biologics" were developed to interfere with very specific parts of the immune responses involved in psoriasis.

It is believed biologics could be safer than some of today's treatments for moderate to severe psoriasis, such as methotrexate, cyclosporine and PUVA, whose potential serious side effects are well-documented.