The US Food and Drug Administration (FDA) has approved peginterferon β-1a (Plegridy, Biogen Idec) as a treatment for adults with relapsing forms of multiple sclerosis (MS), the company announced August 15.
Plegridy is a pegylated version of interferon β-1a, which prolongs the circulation time of the molecule in the body by increasing its size. The process extends the drug's half-life, allowing for a less-frequent dosing schedule.
Peginterferon β-1a, which is dosed once every 2 weeks, is administered subcutaneously with an autoinjector or a prefilled syringe.
The company says the recommended dose of peginterferon β-1a is 125 μg every 14 days. Patients should start treatment with 63 μg on day 1. On day 15, the dose is increased to 94 μg, reaching the full dose of 125 μg on day 29.
The FDA approved peginterferon β-1a based on results of the phase 3 Efficacy and Safety Study of BIIB017 (PEGylated Interferon Beta-1a) in Participants With Relapsing Multiple Sclerosis (ADVANCE) trial, a multicenter, randomized, double-blind, placebo-controlled study involving 1516 patients with relapsing remitting MS.
As reported by Medscape Medical News, peginterferon β-1a dosed once every 2 weeks significantly reduced annualized relapse rate at 1 year by 36% compared with placebo (P = .0007).
The drug also reduced the risk for 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38% (P = .0383) compared with placebo.
With peginterferon β-1a, there was also a significant 86% reduction in the number of new gadolinium-enhancing lesions (P < .0001) and a 67% reduction in new or newly enlarging T2-hyperintense lesions (P < .0001) compared with placebo.
The most common adverse reactions were injection site reaction, influenza-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching, and joint pain.
"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," George A. Scangos, PhD, chief executive officer of Biogen Idec, said in a company news release.
Plegridy is a "compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every 2 week dosing schedule administered by an innovative delivery system," Peter Wade, MD, medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, Connecticut, added in the release. "As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness."
"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," Timothy Coetzee, PhD, chief advocacy, services and research officer at the National MS Society, said in the release.
Peginterferon β-1a was approved by the European Commission in July, as reported by Medscape Medical News.
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Cite this: FDA Clears Peginterferon (Plegridy) for Multiple Sclerosis - Medscape - Aug 18, 2014.