Nerventra laquinimod: Phase III discontinued

Active Biotech said Teva is discontinuing the European Phase III LIBRETTO trial, which was slated to compare daily oral laquinimod vs. weekly intramuscular Avonex interferon beta-1a from Biogen Idec Inc. (NASDAQ:BIIB, Weston, Mass.) in about 600 patients with RRMS. Active Biotech said the trial's design is "no longer aligned with the regulatory strategy" for laquinimod and is a logical step after last month's decision by EMA's CHMP, which recommended against approval of laquinimod because the benefits of the product in RRMS patients do not outweigh the potential risks. Teva has requested a reexamination of CHMP's recommendation, and Active Biotech expects a decision in June (see BioCentury, Jan. 27, 2013). ...