Biogen announced on Aug. 6, 2001, that it has submitted data to the U.S Food and Drug Administration (FDA) to evaluate the use of alefacept (pronounced uh-LEF-uh-sept, and also known by the brand name Amevive) for the treatment of moderate to severe plaque psoriasis. Consumers will probably have to wait until late 2002 before they can get Amevive; it can take the FDA a year or longer to review a new treatment application.
In a study published in the July 26, 2001, issue of the New England Journal of Medicine, Biogen reported treatment with Amevive "is associated with improvement in chronic plaque psoriasis." Reportedly, 28 patients (out of 229 in the phase II study) who received Amevive alone were clear or almost clear of psoriasis after 12 weeks of treatment. Overall, 53 percent of patients improved. The most frequently reported side effects included headache, itching and flu-like symptoms, but were in small numbers of patients.
The Cambridge, Mass., biotechnology company is among the first to use a new electronic filing system that allows companies to submit "BLAs" (biologic license applications) simultaneously in the United States and Europe. By standardizing the way new biologic drugs are submitted for approval, the system may speed the review process, according to the company.
How does Amevive work?
It is now widely accepted that psoriasis is caused by miscues in the human immune system that 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 a humanized monoclonal antibody designed to block a misstep in the immune system -- the activation of T cells. T cells are a type of white blood cell in the body; in psoriasis, once T cells are activated they can trigger other immune responses and fuel the development of psoriasis lesions.
Many of today's treatments for psoriasis work because they suppress or interrupt the immune responses involved in psoriasis. But several of the new medications under development are targeted at a very specific part of the immune response, so in theory they could be more effective and have fewer side effects.
