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Thursday, October 3, 2013

New Data Analyses Show Significant Clinical and MRI Improvements with PLEGRIDY(TM) (Peginterferon Beta-1a)

- Analyses Reinforce Efficacy of PLEGRIDY, Further Supporting a Potential New Treatment Option for People with Multiple Sclerosis --
WESTON, Mass.--(BUSINESS WIRE)--October 01, 2013--

Biogen Idec  announced new data analyses from year one of the two-year, pivotal, Phase 3 ADVANCE study of PLEGRIDY(TM) (peginterferon beta-1a). PLEGRIDY is an investigational subcutaneous injectable for relapsing forms of multiple sclerosis (RMS), in which interferon beta-1a is pegylated to prolong the molecule's exposure in the body and enable the study of a less frequent dosing schedule. Clinical and MRI data from the study demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support the clinical efficacy profile of PLEGRIDY. These data will be presented this week at the 29(th) Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark 2-5 October.
"If approved, PLEGRIDY could become a valuable addition to the interferon class of multiple sclerosis therapies," said Professor Peter Calabresi, MD, director, The Johns Hopkins Multiple Sclerosis Center. "The combination of efficacy demonstrated across key disease measures and a less frequent dosing schedule has the potential to offer an important therapeutic option for people living with MS."
Improvements Seen in Clinical and MRI Endpoints
Over one year, absence of measured disease activity (defined as no relapses, no disability progression, no gadolinium-enhancing [Gd+] lesions and no new or newly enlarging T2-hyperintense lesions compared to baseline) among patients, was significantly higher with PLEGRIDY: 34 percent in the two-week dosing arm (p<0.0001) and 22 percent in the four-week dosing arm (p=0.01), compared to 15 percent in the placebo arm.
In the intent-to-treat population of the ADVANCE study, PLEGRIDY, when dosed every two weeks, significantly reduced the number of new or newly enlarging T2-hyperintense lesions, new T1-hypointense lesions, new Gd+ lesions and new active lesions compared to placebo at 48 weeks. Specifically, PLEGRIDY reduced the number of:


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