Elan, Biogen Idec submit Tysabri sBLA

ELN and BIIB submitted an sBLA to FDA for Tysabri natalizumab to treat multiple sclerosis (MS). The submission included the safety evaluation that was reported last month; a revised label and risk management plan; and two-year data from the Phase III AFFIRM monotherapy trial and the Phase III SENTINEL trial of Tysabri plus Avonex interferon beta-1a. The companies requested Priority Review. ...