FDA to complete Amevive review within 6 months
First posted Sept. 13, 2002
Biogen announced yesterday that the U.S. Food and Drug Administration (FDA) has committed to complete the review of the drug alefacept (brand name Amevive) within six months. Biogen originally submitted its application for FDA approval in August 2001. At a FDA advisory committee meeting in May, the FDA heard a summary of all of the information from Biogen's clinical trials and public testimony, including testimony from NPF representatives. The FDA requested more information in early June 2002, to which Biogen responded. Amevive was developed for the treatment of moderate to severe plaque psoriasis. Consumers will probably have to wait until the first quarter of 2003 before they can get Amevive.
While other systemic therapies are used to treat psoriasis by suppressing the immune system, Amevive is known as a "biologic," which blocks the activation of specific T cells in the immune system that trigger the development of psoriasis lesions. Psoriasis affects approximately 4.5 million people in the United States. Plaque psoriasis affects approximately 4 out of 5 people with psoriasis. For more information about biologics, please go here.
How is it different?
Amevive is one of many "biologic response modifiers" that has been in development and testing for psoriasis and psoriatic arthritis. This new class of drug is genetically engineered to block key interactions between cells in the immune system involved in these diseases. Other treatments for psoriasis and psoriatic arthritis, particularly those used in moderate to severe cases, can have a widespread impact on the immune system.
Amevive is a humanized monoclonal antibody designed to block a misstep in the immune system of people who have psoriasis -- the over-activation of T cells. T cells are a type of white blood cell in the body; in psoriasis, once T cells are mistakenly activated, they can trigger other immune responses and fuel the development of psoriasis lesions.
How effective is Amevive?
Similar to etanercept (brand name Enbrel), Amevive is a maintenance drug. Once it is stopped, the symptoms of the disease return.
At a scientific meeting in early 2001, investigators reported results of a phase III clinical trial of Amevive in more than 1,000 patients. Among patients who received one course of Amevive by intravenous (IV) injection, 28 percent achieved a 75 percent or greater improvement in their psoriasis. Fifty-six percent of patients achieved 50 percent improvement in their disease.
One course of treatment consisted of 12 weekly injections. Investigators determined there was cumulative benefit from Amevive. After a second 12-week course of treatment, 40 percent of patients achieved a 75 percent or greater improvement in their disease, and 71 percent reached 50 percent improvement.
The trial included 205 patients at 17 clinics across the country.
What are the side effects?
In the phase III trial, there was no evidence of toxic reaction in patients to the drug and no psoriasis rebounds after patients stopped treatment with Amevive, according to researchers. The most frequently reported side effects included headache, itching and flu-like symptoms, but these were in small numbers of patients.
How will I get it?
Biogen will set up a customer support number for any customer questions. The cost of Amevive to consumers has yet to be assessed. However, company representatives report it may be similar to the cost of Enbrel, a "biologic response modifier" that targets specific interactions in the immune system and is approved for the treatment of psoriasis. Prescriptions of Enbrel cost approximately $1,000 per month. The cost for patients may vary depending on their health insurance coverage.
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