Psoriasis Foundation to Testify Before FDA Panel Reviewing New Psoriasis Drug
September 9 hearing on Raptiva approval
First posted Sept. 3, 2003
The National Psoriasis Foundation will testify Sept. 9 before a U.S. Food and Drug Administration (FDA) committee on the need for new treatments for psoriasis. The committee is meeting to evaluate the application of efalizumab, also known by the brand name Raptiva, for the treatment of moderate to severe plaque psoriasis in adults. Leslie Holsinger, Ph.D., chairman of the Psoriasis Foundation Board of Trustees, and two Psoriasis Foundation members will speak before the FDA's Dermatologic and Ophthalmic Drug Advisory Committee (DODAC).
"Psoriasis has severely impacted my life," said Holsinger, a psoriasis patient for more than 15 years. "By sharing my story, I hope the FDA will better understand the urgency felt in the psoriasis community for more treatment options."
Raptiva is a systemic biologic therapy manufactured by Genentech and Xoma. The companies filed for FDA approval in December 2002. DODAC 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 Psoriasis Foundation has testified before the FDA multiple times to support the approval of new therapies for psoriasis. As an organization, the Psoriasis 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.
Raptiva may join growing biologic class
Raptiva is an antibody that blocks the activation of certain immune cells, called "T cells," and the migration of those cells into the skin. T cells are a type of white blood cell in the body that normally help us ward off foreign invaders and fight infection. In psoriasis, however, these T cells are mistakenly activated and trigger other immune responses that fuel the development of psoriasis lesions. Raptiva is given by weekly subcutaneous (under the skin) self-injection.
The FDA will evaluate Raptiva's safety and efficacy by reviewing data from extensive clinical studies. For example, researchers recently presented findings that 44 percent of patients treated continuously with Raptiva for 24 weeks saw the severity of their psoriasis improve by 75 percent or more. A longer study, where patients taking Raptiva weekly were monitored for 21 months, showed that 67 percent of patients achieved a 75 percent improvement in psoriasis severity.
The most common side effects reported from the phase III trials were headache, infection (such as common colds), chills, nausea and pain (unrelated to injection), with most reactions occurring after the first one or two injections during the initial 12-week treatment. By the third injection, side effects were similar to those on placebo. No new side effects were observed during long-term Raptiva therapy. The number of adverse events decreased over time from 57 percent during months 4 to 6 to nearly 50 percent from months 16 to 18.
In January 2003, Amevive (pronounced AM-uh-veev), manufactured by Biogen, became the first biologic medication to be approved for treating psoriasis. Enbrel, manufactured by Amgen and co-marketed by Wyeth, was approved for psoriatic arthritis in January 2002. These and other medications are part of this new class of drugs, which interfere with very specific parts of the immune responses involved in psoriasis.
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.
According to the FDA Web site:
- The FDA may seek a committee's opinion about a new drug, a major new indication for an already approved drug, or a special regulatory requirement being considered, such as a boxed warning in a drug's labeling.
- The committees may advise FDA on necessary labeling information, and help with guidelines for developing particular kinds of drugs, such as those for anesthesia, heartbeat irregularities, and cancer.
- They also may address such questions as whether a proposed study for an experimental drug should be conducted and whether the safety and effectiveness information submitted for a new drug is adequate for marketing approval.
DODAC will meet from 8:00 a.m. to 5:30 p.m. Eastern Daylight Time at the Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, Md. Public testimony will be heard between approximately 1 p.m. and 2 p.m.
Resources
The following links take you off the National Psoriasis Foundation Web site. We are not responsible for the content of any linked site.
The agenda, list of participants and briefing statement is available at the FDA Web site, under Dermatologic and Ophthalmic Drugs Advisory Committee.
For those interested, a live Webcast of the FDA advisory committee meeting is available for $150 through the private company www.fdaadvisorycommittee.com. Otherwise, stay tuned to this Web site and Psoriasis Foundation publications for news about the meeting.
Genentech also will broadcast a free Webcast after the FDA hearing at www.gene.com. It will be available for viewing until 5:00 p.m. Pacific time, Sept. 16.
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