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SundayPlegridy approved by FDA for multiple sclerosisThe U.S. Food and Drug Administration (FDA) has approved Plegridy as the new multiple sclerosis treatment by Biogen Idec. The approval of the drug is based on phase 3 clinical trials in which the drug Plegridy (peginterferon beta-1a) was administered to 1,500 MS patients and it was observed that during the first year 12-week disease progression was reduced by 38 percent when compared to placebo. It is the only pegylated beta interferon that is approved for being used in case of relapsing MS and is applied through a pre-filled syringe every two weeks. The drug is now cleared from FDA and also from the European regulatory authorities. The company already markets three other MS treatments Avonex (interferon beta-1a), Tecfidera (dimethyl fumarate) and Tysabri (natalizumab). The company however said that it faces stiff competition in the ever evolving MS market and faces competition from various eminent pharma companies. Currently the company said that it has no plans for an extended indication of the drug.
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Labels: Plegridy, TECFIDERA, Tysabri |