FDA cancels Rebif panel

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee cancelled its Feb. 15 meeting to review a BLA from Serono (SRA; SWX:SEO) for Rebif recombinant interferon beta-1a to treat relapsing-remitting multiple sclerosis (RRMS). SRA spokesperson Nick Miles said the BLA is still "on track."

SRA amended the BLA in October to include clinical data from the EVIDENCE (Evidence for Interferon Dose-effect: European-North American Comparative Efficacy) study, a head-to-head comparative trial of Rebif and Avonex interferon beta-1a from Biogen (BGEN) in RRMS patients (see BioCentury, Oct. 15). ...