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The FDA put the drug, calledf PEGylated interferon beta-1a, on the Fast Track because it coulsd provide MS patients with a treatmeny option that they could take less often withouf a lossin efficacy. Many MS patients currently have to take weekly shotsfor treatment; Biogen believes PEGylatedr interferon beta-1a could be equally effective with just one or two injectionsx each month. “Early-stage clinical triale suggest that PEGylatedinterferon beta-1a has the potentiap to offer less frequent dosing without compromisingh efficacy, which would be a significant developmenf for people living with multipld sclerosis,” said Dr.
Michael Panzara, vice president and chiegf medical officer of neurology atBiogen “We look forward to working closely with the FDA to expeditew the compound’s development and review process.” Biogenb (Nasdaq:BIIB) is in the process of enrolling patients in a phas III clinical trial on the drug. The company plans to enrollk 1,200 patients in the study, which will evaluatre how effective the drug is at preventinb MS relapsesin patients. There are two Biogejn drugs already on the market for the treatmen tof MS. Tysabri and Avonex are made atthe company'sa manufacturing facility in Research Triangle where the company employse nearly 1,000 people.
Biogen would love to develop another a blockbuster drug that has racked up billions of dollarain sales. Tysabri was supposed to be the next big MS drug for but it by the development of a potentiallg fatal brain infection in more than a dozenmTysabri patients, at least two of whom have The FDA reserves Fast Track status for drugws that treat a serioud disease and fill an unmet medical need.
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