Today Biogen Idec announced in its press release the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY™ (peginterferon beta-1a) for the treatment of relapsing remitting form of multiple sclerosis.
The submission was made based on the results of the 2 year long global ADVANCE study. Plegridy is administered subcutaneously, or under the skin, which can be less painful. The study included 1,516 people with relapsing forms of MS and randomly assigned participants to doses of PEGylated interferon beta-1a once every 2 or 4 weeks or placebo. The press release states “the study data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.” After completing two years in the ADVANCE study, patients have the option of enrolling in an open-label extension study called ATTAIN and will be followed for up to four years.
You can find further background about this product in this MultipleSclerosis.net products in development article, including information on phase 1 and phase 2 studies.
If approved, Plegridy could become an additional interferon treatment option for MS patients with a less frequent dosing schedule than that of currently approved interferons.
This submission arrives after the recent approval of Tecfidera, an oral treatment for the treatment of relapsing remitting MS. Biogen Idec also manufactures Avonex and Tysabri for the treatment of Multiple Sclerosis.1