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National Psoriasis Foundation to testify before FDA panel reviewing new psoriasis drug

First posted May 6, 2002

The National Psoriasis Foundation will testify May 23 before a U.S. Food and Drug Administration (FDA) committee on the need for new treatments for psoriasis. Gail M. Zimmerman, National Psoriasis Foundation president and CEO, will provide the testimony with the help of several Foundation members during a meeting of the FDA's Dermatologic and Ophthalmic Drug Advisory Committee (DODAC).

The committee is meeting to evaluate the application of alefacept (pronounced uh-LEF-uh-sept, and also known by the brand name Amevive) for the treatment of moderate to severe psoriasis plaque psoriasis in patients who are candidates for phototherapy or systemic (oral or injected) medications.

Amevive, made by Biogen, a Cambridge, Mass., biotechnology company, was submitted to the FDA for approval in early August 2001. DODAC, which is chaired by Robert Stern, M.D., professor of dermatology at Boston's Beth Israel Deaconess Medical Center, will make a recommendation to the FDA about the drug's safety and effectiveness and whether it should be approved for treating psoriasis.

Since it was founded in 1968, the National Psoriasis Foundation has testified before the FDA several times to support the approval of new therapies for psoriasis. As an organization, the Foundation 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 biologic age begins
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.

Amevive (pronounced AM-uh-veev) is the first of a new wave of targeted therapies for psoriasis to come up before the FDA. These new therapies, called "biologics" as a class, are created to interfere with very specific parts of the immune responses involved in psoriasis. It is believed biologics could be effective and safer than today's treatments for moderate to severe psoriasis, although the long-term side effects of these new drugs are not yet known.

Several other biologics are also far along in the development process, and more new treatments for moderate to severe psoriasis could be approved in the next five years than were in the past 20 years.

Amevive is a humanized monoclonal antibody designed to block the activation of T cells, a type of white blood cell in the body. In psoriasis, T cells are inappropriately activated, and they can trigger other immune responses and fuel the development of psoriasis lesions.

The FDA review process
The FDA is the federal agency charged with protecting public health by reviewing and monitoring a wide variety of products -- from common food ingredients to complex surgical devices to cutting-edge medical treatments.

The DODAC will meet from 8:00 a.m. to 5 p.m. at the Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, Md. Public testimony will be heard between approximately 1 p.m. and 2 p.m. Those desiring to to make formal oral should notify the FDA before May 17 by calling the FDA Advisory Committee Information Line, (800) 741-8138, code 12534.

For those interested, a live Webcast of the FDA advisory committee meeting is available for $150 through the private company www.FDAlive.com. Otherwise, stay tuned to this Web site and National Psoriasis Foundation publications for news about the meeting.

Here is the purpose and function of FDA advisory committees, according to the agency's Web site:

• "Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies. Advisory committees schedule meetings to consider the applications and reviews for drugs in specialized medical areas, such as cancer or heart disease.

  "The marketing applications include data to show the safety and effectiveness of human drugs. The outside experts receive summary information about the applications and copies of FDA's review of the application documents. Based on this information, advisory committees may recommend approval or disapproval of a drug's marketing application. They may also ask for more information before they can make a recommendation. FDA generally follows an advisory committee's recommendation, but is not bound to do so."