In addition to the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for peginterferon beta-1a to the European Medicines Agency (EMA) in the coming weeks.Peginterferon beta-1a 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. Peginterferon beta-1a s 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.
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 peginterferon beta-1a in 1,516 patients with relapsing-remitting MS.
“Why did Biogen-Idec go for the subcutaneous route, when their other compound is so well tolerated as an intramuscular preparation?”
“Is there space in the market for another interferon? Would you go for an injection every 2 or 4 weeks, over a weekly or more frequent injection?”
For full article: Business Wire 05/21/2013 4:30 AM ET
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CoI: multiple, The Royal London Hospital was a site in the ADVANCE study.