Biogen Idec has announced that the European Commission has granted marketing authorisation for Plegridy (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). Plegridy is dosed once every two weeks and is administered subcutaneously with the Plegridy pen, a new ready-to-use autoinjector, or a prefilled syringe.
Plegridy, the only pegylated interferon approved for use in relapsing-remitting multiple sclerosis, has been proven to significantly reduce important measures of disease activity, including number of relapses, MRI brain lesions, and disability progression.
The European Commission approval of Plegridy is based on results from one of the largest pivotal studies of a beta interferon conducted, ADVANCE, which involved more than 1,500 patients with relapsing forms of multiple sclerosis.
In the ADVANCE clinical trial, Plegridy, dosed once every two weeks, significantly reduced annualised relapse rate (ARR) at one year by 36% compared to placebo (p=0.0007).
Plegridy reduced the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks by 54% (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86% (p<0.0001) compared to placebo.
Results over two years of ADVANCE confirm that its robust efficacy was maintained beyond the placebo-controlled first year of the study.
“The safety and efficacy that Plegridy has demonstrated, combined with its less frequent dosing schedule offers multiple sclerosis patients an option to put their treatment in the background for longer stretches of time,” says Bernd C Kieseier, Heinrich-Heine Universität, Dusseldorf.
The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE was consistent with that of established multiple sclerosis interferon therapies. The most commonly reported adverse drug reactions with peginterferon beta-1a treatment (incidence ≥10% and at least 2% more frequent on peginterferon beta-1a than on placebo) were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching, and joint pain.
Plegridy is the fifth therapy to be offered by Biogen Idec to people living with multiple sclerosis.