The FDA granted Biogen Idec’s BIIB017 fast track designation to treat relapsing multiple sclerosis (RMS), the drugmaker reported Wednesday. The company’s chief medical officer of neurology, Michael Panzara, noted that early-stage data suggest the drug candidate “has the potential to offer less frequent dosing without compromising efficacy.”

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Biogen Idec said it is in the process of recruiting 1200 patients with RMS for the Phase III ADVANCE trial. The randomised, placebo-controlled study will assess the efficacy of either bi-weekly or once-monthly injections of the compound to reduce relapse rates at one year.

The trial will also examine if treatment with BIIB017, also known as PEGylated interferon beta-1a, can slow disease progression over time and decrease the number of T2 hyperintense brain lesions commonly observed in patients with MS.

Source: FirstWord

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