16.08.2014 01:04:45
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Biogen Idec: FDA Approves Plegridy To Treat Multiple Sclerosis
(RTTNews) - Biogen Idec (BIIB) said Friday the U.S. Food and Drug Administration approved Plegridy as a new treatment for people with relapsing forms of multiple sclerosis.
Plegridy, the only pegylated beta interferon approved for use in relapsing forms of multiple sclerosis (RMS), is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.
The FDA approval is based on a study whereby Plegridy showed a reduction in relapses, disability progression and the number of MS lesions when compared with placebo. The safety and tolerability profile of Plegridy was consistent with that of established MS interferon therapies.
The most common adverse reactions were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain.
Plegridy was recently approved by the European Commission.
Biogen Idec stock closed Friday at $342.47, up $5.46 or 1.62%, on a volume of 1.5 million shares on the Nasdaq. In after hours, the stock gained $2.53 or 0.74% at $345.
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Biogen Inc | 128,10 | -6,73% |
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