Biogen Idec Receives Positive CHMP Opinion For Plegridy As Treatment For MS

By RTT News, May 23, 2014, 08:12:00 AM EDT

(RTTNews.com) - Biogen Idec ( BIIB ) said Friday that it received a positive recommendation from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA for the marketing authorization of Plegridy (peginterferon beta-1a), a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis or RRMS.

The CHMP's positive opinion is now referred to the European Commission (EC), which grants marketing authorization for medicines in the EU.

Following the opinion adopted by the CHMP, a decision from the EC is expected within the coming months.

Plegridy is an investigational subcutaneous injectable therapy for relapsing-remitting multiple sclerosis, in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body. Plegridy is a member of the interferon class of treatments for MS.

Clinical and MRI data from the ADVANCE study of PLEGRIDY demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support its clinical efficacy profile.

Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves. Relapsing forms of MS include: relapsing-remitting MS, the most common form of the disease accounting for 85 percent of cases, which is characterized by clearly defined acute attacks with full recovery or with residual deficit upon recovery; and progressive-relapsing MS, which affects percent of people with MS and is characterized by steadily worsening disease from the beginning with occasional acute attacks like those experienced by people with RRMS.

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Biogen Idec Receives Positive CHMP Opinion For Plegridy As Treatment For MS