Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based biotechnology firm Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its Plegridy (peginterferon beta-1a) for the treatment of people with relapsing forms of multiple sclerosis (RMS).
Subscribe to our email newsletter
The company said that Plegridy is the only pegylated beta interferon approved to use in RMS, which is dosed once every two weeks.
The drug can be administered subcutaneously with the Plegridy Pen, a ready-to-use autoinjector, or a prefilled syringe.
The subcutaneous injectable therapy is 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.
Biogen Idec CEO Dr George Scangos said Plegridy provides 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," Scangos said.
The approval was based on results from pivotal trials of beta interferon conducted, ADVANCE, which included over 1,500 patients with MS.
ADVANCE, the two-year, Phase III placebo-controlled trial, evaluated the efficacy and safety of Plegridy administered subcutaneously.