Durata Therapeutics, Inc. Receives Positive Scientific Advice from European Medicines Agency (EMA)
5/4/2011 11:25:51 AM
MORRISTOWN, N.J.--(BUSINESS WIRE)--Durata Therapeutics today announced the Company has received positive Scientific Advice from the European Medicines Agency (EMA) on the pivotal clinical development plan for dalbavancin, Durata’s long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). The EMA’s Advice is in concert with the output of a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). Based on this comprehensive body of regulatory guidance, Durata is conducting a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin, initiated in March of this year.