Biogen-Idec MS drug put on FDA Fast Track - Atlanta Business Chronicle:

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The FDA put the drug, called PEGylatefd interferon beta-1a, on the Fast Track becaus it could provide MS patients with a treatmenf option that they could take less often without a loss in Many MS patients currently have to take weeklgy shotsfor treatment; Biogen believes PEGylated interferoj beta-1a could be equally effective with just one or two injectionds each month. “Early-stage clinical trialsd suggest that PEGylatedinterferon beta-1a has the potential to offer less frequent dosing without compromising which would be a significant development for people living with multiple sclerosis,” said Dr. Michael vice president and chief medical officer of neurology atBiogen Idec.
“We look forward to workin g closely with the FDA to expeditethe compound’es development and review process.” Biogenb (Nasdaq:BIIB) is in the proceszs of enrolling patients in a phas III clinical trial on the The company plans to enrolk 1,200 patients in the which will evaluate how effective the drug is at preventingv MS relapses in patients. There are two Biogejn drugs already on the market for the treatmenyof MS. Tysabri and Avonez are made atthe company's manufacturing facility in Research Triangle where the company employs nearly 1,000 people. Biogen would love to develop another a blockbuster drug that has racked up billions of dollarwin sales.
Tysabri was supposed to be the next big MS drug for but it by the development of a potentially fatal braih infection in more than a dozenTysabr patients, at least two of whom have died. The FDA reservew Fast Track status for drugs that treat a serious diseass and fill an unmetmedical need.