Biogen Idec receives marketing authorization from EC for multiple sclerosis drug

Jul 25 2014

Reduces Relapses, Disability Progression, and MRI Brain Lesions, with a Favorable Safety Profile Consistent with the Established Interferon Class

Today Biogen Idec (NASDAQ: BIIB) announced that the European Commission (EC) has granted marketing authorization for PLEGRIDY^TM (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.

“Peginterferon beta-1a is an exciting new addition to our portfolio of MS treatments and offers people living with MS in the UK an interferon with compelling efficacy that requires fewer treatment days than other platform therapies," said Terry O’Regan, Vice President and Managing Director UK and Ireland, Biogen Idec. “The approval of peginterferon beta-1a demonstrates our commitment to improving the lives of patients by providing innovative therapies that meet their individual needs, including flexibility in managing their disease.”

Peginterferon beta-1a, the only pegylated interferon approved for use in RRMS, has been proven to significantly reduce important measures of disease activity, including number of relapses, MRI brain lesions, and disability progression.

The EC approval of peginterferon beta-1a 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 MS.

In the ADVANCE clinical trial, peginterferon beta-1a, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007).

Peginterferon beta-1a reduced the risk of sustained disability progression confirmed at twelve weeks by 38 percent (p=0.0383) and at twenty four weeks by 54 percent (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86 percent (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.

“Poor adherence to treatment remains a key challenge in the treatment of MS. The European marketing authorisation of peginterferon beta-1a is a significant step forward in the treatment of RRMS as it offers a less frequent dosing schedule than existing treatments. In clinical trials, peginterferon beta-1a  has demonstrated robust efficacy and a high compliance rate, with a safety profile consistent with the interferon class, making it an important addition to the MS treatment armoury,” said Dr Ben Turner, Consultant Neurologist at Barts and The London NHS Trust.

“It is important for patients with MS to not only have a treatment that is effective but also one that complements their lifestyle. Peginterferon beta-1a combines robust clinical efficacy with a reduced dosing regimen and high compliance rate, representing a fantastic development in the treatment of patients with RRMS,” said Barbara Wingrove, MS Specialist Nurse at City Hospitals Sunderland NHS Foundation Trust.

The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE was consistent with that of established MS 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.

Peginterferon beta-1a is the fifth therapy to be offered by Biogen Idec to people living with MS, expanding on a portfolio that addresses individual patient needs.