July 23, 2014
Today Biogen Idec announced that the European Commission (EC) has granted marketing authorization for PLEGRIDYTM(peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). PLEGRIDY is dosed once every two weeks and is administered subcutaneously with the PLEGRIDY PEN, a new ready-to-use autoinjector, or a prefilled syringe.
“PLEGRIDY offers people living with MS an interferon with compelling efficacy that requires considerably fewer injections than other platform therapies,” said George A. Scangos, Ph.D., chief executive officer at Biogen Idec. “The approval of PLEGRIDY demonstrates our commitment to improving the lives of patients by providing innovative therapies that meet their individual needs, including flexibility in managing their disease.”
PLEGRIDY, the only pegylated interferon approved for use in RRMS, has been proven to significantly reduce important measures of disease activity, including number of relapses, MRI brain lesions, and disability progression.
The EC approval of PLEGRIDY is based on results from one of the largest pivotal studies of a beta interferon conducted, ADVANCE1, which involved more than 1,500 patients with relapsing forms of MS.
In the ADVANCE clinical trial, PLEGRIDY, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo
Read more, Including Safety and tolerability, found here
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