Biotechnology firm Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (RMS).
Plegridy is a subcutaneous injectable therapy indicated for relapsing forms of MS, in which interferon beta-1a is pegylated to extend its half-life to permit a less frequent dosing schedule.
According to the company, Plegridy is the only pegylated beta interferon approved to use in RMS, which is dosed once every two weeks.
The treatment can be administered subcutaneously with the Plegridy Pen, a ready-to-use autoinjector, or a prefilled syringe.
Biogen Idec CEO Dr George Scangos said: "Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments.
"Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them."
Plegridy’s FDA approval was based on results from pivotal studies of beta interferon conducted, Advance, which involved around 1,500 patients with MS.
Advance was a two-year and phase three placebo-controlled (in year one) study, which evaluated the efficacy and safety of Plegridy administered subcutaneously.
Biogen noted that Plegridy was recently approved by the European Commission.
Image: The Plegridy pen, a ready-to-use autoinjector for subcutaneous administration. Photo: courtesy of Business Wire.
