“In the first year of the ADVANCE trial, PLEGRIDY demonstrated strong efficacy. We saw a marked reduction in relapse rate and this was supported by MRI results. If approved, PLEGRIDY will make an important therapeutic option in the injectable treatment segment”, said Gilmore O’Neill, Vice President, Global Neurology Late Stage Clinical Development at Biogen Idec. “In addition to these encouraging therapeutic results, PLEGRIDY may reduce the treatment burden for patients by reducing the number of subcutaneous injections.”
PLEGRIDY showed favorable safety and tolerability profiles in ADVANCE. The overall incidence of serious adverse events (SAEs) and adverse events (AEs) was similar among the PLEGRIDY and placebo groups. The most common SAE was infections, which was balanced across all treatment groups (≤1 percent per group). The most commonly reported AEs with PLEGRIDY treatment were redness at the injection site and influenza-like illness.
PLEGRIDY is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. PLEGRIDY is a member of the interferon class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line treatment for MS.
After completing two years in the ADVANCE study, patients have the option of enrolling in an open-label extension study called ATTAIN and will be followed for up to four years.For members of the media interested in more information and additional resources, please visit www.biogenidec.com/us_media_corner. About ADVANCE The two-year Phase 3 ADVANCE clinical trial is a global, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy and safety of PLEGRIDY in 1,516 randomized patients with RRMS. The study investigates two dose regimens of PLEGRIDY, 125 mcg administered subcutaneously every two weeks or every four weeks compared to placebo. The analysis for all primary and secondary efficacy endpoints occurs at one year. After the first year, patients on placebo are re-randomized to one of the PLEGRIDY arms for the duration of the second year of the study.