Whether Amevive was the cause is unclear, but overall the drug was as safe as placebo.
Genentech's Raptiva, which is similar to Amevive, could be approved by the end of the year.
That's true even though Amevive, for psoriasis, and Zevalin, for lymphoma, have been small sellers for Biogen.
Also, Biogen faces heavy competition with two of its big drugs: Avonex (multiple sclerosis) and Amevive (psoriasis).
In 1995 Biogen began clinical trials of Amevive, ultimately testing it in 1, 300 humans over six years.
Should Amevive win the FDA's okay, Biogen plans to establish a registry of patients to do that.
The drawback is that because Amevive fiddles with the T cell process, the drug may leave patients vulnerable to infection.
This morning, Biogen announced that the Food and Drug Administration has approved its drug Amevive as a treatment for psoriasis.
There have been concerns that because Amevive works by deadening the immune system, it might decrease patients' ability to fight infections.
Late-stage trials ended in May 2001, and the results were impressive:Of 1, 100 patients injected with Amevive, 40% achieved a 75% reduction in the severity of psoriasis.
Biogen's Amevive has already been approved by the Food and Drug Administration, although it does appear to suppress the immune systems of a handful of patients.
As the FDA panel reviewed Amevive in May, Biogen Chief Executive James Mullen anxiously watched a broadcast of the daylong proceedings with 300 employees in the Biogen auditorium.
Biogen 's (nasdaq: BGEN - news - people ) Amevive has already been approved to treat psoriasis, but must be given in a doctor's office.
Prominent among these drugs is Amevive, a remedy for severe psoriasis, an autoimmune disorder that causes scaly rash in 7 million Americans (see FORBES, July 22, p. 208).
Amevive is the first treatment for psoriasis, a skin disease that affects some 4 million patients in the U.S. It occurs because patients' immune systems run amok for unknown reasons, causing painful lesions and rashes.
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