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news.Astellas Pharma and Theravance have submitted a marketing authorization application to the European Medicines Agency for its antibiotic telavancin, which can treat MRSA.
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In two large, multinational, double-blind, randomized phase III clinical studies that enrolled and treated 1,867 patients in total, 719 of whom had infections with methicillin-resistant Staphylococcus aureus (MRSA), telavancin achieved its primary endpoint of non-inferiority in both studies.
Astellas said that Telavancin compared favorably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections.
Masafumi Nogimori, president and CEO of Astellas, said: “Following the US NDA filing of telavancin in February 2007, I am pleased to announce that the EU submission of telavancin to the MAA is on schedule.”