European Medicines Agency Completes Validation Phase for the Telavancin MAA for the Treatment of Nosocomial Pneumonia and Complicated Skin and Soft Tissue Infections
Mon, 11/30/2009 - 3:56am
Theravance, Inc. announced today that the European Medicines Agency (EMEA) has completed the validation phase for the Marketing Authorization Application (MAA) for telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia (NP), including ventilator-associated pneumonia, and complicated skin and soft tissue infections (cSSTI) in adults. Astellas Pharma Europe B.V., a European affiliate of Astellas Pharma Inc. (Astellas), submitted the MAA in October 2009 under the Centralized Procedure and applied for marketing authorization for telavancin in the Member States of the European Union (EU), plus Iceland, Liechtenstein and Norway. The successful completion of the validation phase for a MAA signifies that the submission is administratively complete and that EMEA's scientific review process has begun. "We are pleased that EMEA has initiated its scientific review of the telavancin MAA for nosocomial pneumonia and complicated skin and soft tissue infections," said Rick E Winningham, Chief Executive Officer at Theravance. "We remain focused on our goal of gaining approval for telavancin and bringing its benefits to patients with these serious infections in Europe."