EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Synageva BioPharma Corp. (NASDAQ: GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, today announced validation by the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for sebelipase alfa for LAL Deficiency. The EMA recently granted the company's request for accelerated assessment, which has the potential to shorten the EMA's regulatory review time.

The MAA, and the Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA), include previously reported data from the global, randomized, double-blind, placebo controlled Phase 3 trial of sebelipase alfa in children and adults with LAL Deficiency, and the Phase 2/3 trial of sebelipase alfa in infants with LAL Deficiency. Patients in these trials, combined with patients in other ongoing clinical trials with sebelipase alfa, represent the largest patient population studied to date for this rare, devastating disease.