EMEA receives telavancin MAA

The European unit of Japanese drug major Astellas and USA-based Theravance have submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for telavancin, a rapidly-bactericidal injectable antibiotic with a unique multifunctional mechanism of action, for the treatment of complicated skin and soft tissue infections in adults.

In two large, multinational, double-blind, randomized Phase III studies that enrolled and treated 1,867 patients in total, 719 of whom had infections with methicillin resistant Staphylococcus aureus, telavancin achieved its primary endpoint of non-inferiority 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, the companies stated.