About Multiple Sclerosis Foundation



Home > Learn About Multiple Sclerosis > News > Plegridy™ Review Extended for Three Months

Plegridy™ Review Extended for Three Months

3/19/2014

Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has extended its review of Biogen Idec’s drug candidate Plegridy™ (peginterferon beta-1a) for relapsing forms of multiple sclerosis (RMS) by another three months. Three months is the standard extension period for the Prescription Drug User Fee Act (PDUFA) date. The FDA has indicated that the extension of the PDUFA date is required to allow additional time for review of the application. The agency has not asked for additional studies, according to Biogen.

Plegridy is a new molecular entity 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, which is often used as a first-line treatment for MS. Regulatory authorities in the United States accepted the marketing applications for the review of Plegridy in RMS in 2013.

 



  Support the MSF
Supporting MSF's programs to help make "a brighter tomorrow" has never been easier.
make a donation 

  Learn About MS
Common symptoms of MS include fatigue, weakness, spasticity, balance problems, bladder and bowel problems, numbness, vision loss, tremors and depression.
learn more 

 

Unless otherwise specified, all medical content is compiled by MSF staff and reviewed for accuracy by a member of our Medical Advisory Board.

The MSF strives to present clear and unbiased information. This site is partially funded through a grant from Bayer Healthcare, LLC.

© Copyright 2000-2013 Multiple Sclerosis Foundation - All Rights Reserved