The FDA has approved peginterferon beta-1a (Plegridy), a groundbreaking injectable therapy for patients with relapsing forms of multiple sclerosis.
The FDA has approved peginterferon beta-1a (Plegridy), a groundbreaking injectable therapy for patients with relapsing forms of multiple sclerosis (MS).
The interferon beta treatment is self-administered subcutaneously once every 2 weeks by patients with a new, ready-to-use autoinjector device developed by the drug’s manufacturer, Biogen Idec.
In a company statement, Biogen CEO George A. Scangos, PhD, claimed that Plegridy “represents the most significant innovation in the interferon class in over a decade.” The drug, which also gained approval in Europe, has a simpler dosing schedule than interferon beta-1a (Avonex), Biogen’s once-weekly interferon therapy for relapsing forms of MS.
“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,” Scangos noted.
The FDA based its approval of Plegridy on safety and efficacy results from the 2-year, Phase 3 ADVANCE trial that involved more than 1500 MS patients, which made it one of the largest pivotal studies of beta interferon ever conducted. After the first year of the trial, those who were originally randomized to administer placebo were given Plegridy for the duration of the study.
Compared to placebo, Plegridy dosed once every 2 weeks significantly reduced the annualized relapse rate by 36% and reduced the risk of 12-week confirmed disability progression by 38% in the first year of the trial. The interferon beta treatment also significantly reduced the number of new gadolinium-enhancing lesions by 86% and reduced new or newly enlarging T2-hyperintense lesions by 67% compared to placebo.
The most common adverse reactions in the ADVANCE trial were “injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain,” the Biogen announcement said.
“Plegrity is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy, and an every two week dosing schedule administered by an innovative delivery system,” said Peter Wade, MD, medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research. “As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.”
Timothy Coetzee, PhD, chief advocacy, services, and research officer at the National MS Society, added, “It is always encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever.”