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Multiple Sclerosis Drug Plegridy (Peginterferon) Submitted for FDA Review
A biologics license application (BLA) has been submitted to the FDA for approval of Plegridy (peginterferon beta-1a; Biogen Idec), a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS).
The regulatory submission was based on results from the first year of the 2-year phase III ADVANCE trial involving 1,516 patients with relapsing-remitting MS. In this study, Plegridy met all primary and secondary endpoints at 1 year by significantly reducing disease activity — including relapses, disability progression, and brain lesions — compared with placebo, and showed favorable safety and tolerability profiles.
Plegridy is a new molecular entity in which interferon (IFN) beta-1a is pegylated to extend its half-life and to prolong its exposure in the body. (Pegylation is the process of covalent attachment of polyethylene glycol [PEG] polymer chains to another molecule.) The drug is a member of the IFN class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line therapy for MS.
The ADVANCE trial is investigating two dosing regimens of Plegridy — 125 mcg administered subcutaneously every 2 weeks or every 4 weeks — compared with placebo. The analysis for all primary and secondary efficacy endpoints occurred at 1 year. After the first year, patients receiving placebo were re-randomized to one of the Plegridy arms for the duration of the second year of the study. After completing 2 years in the ADVANCE trial, the patients will have the option of enrolling in an open-label extension study (ATTAIN) and will be followed for up to 4 years.
Source: Biogen Idec; May 21, 2013.