Japan’s Astellas Pharma says that it has submitted a marketing authorisation application to the European Medicines Agency for telavancin, a rapidly bactericidal injectable antibiotic developed by partner Theravance of the USA.
Astellas has filed telavancin, which it says has a unique multifunctional mechanism of action, for the treatment of complicated skin and soft tissue infections in adults. The application is based on two double-blind, randomised Phase III clinical studies (ATLAS 1 and ATLAS 2) that enrolled and treated 1,867 patients, 719 of whom had infections with methicillin-resistant Staphylococcus aureus.
Telavancin achieved its primary endpoint of non-inferiority in both studies, Astellas said, noting that the compound compared favourably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates and its safety profile was compatible with treatment of patients with serious infections. The firm filed a New Drug Application in the USA for telavancin in February this year.
Advagraf approved in Europe
The telavancin submission comes days after Astellas said on Friday it had received European approval to market Advagraf, a once-daily version of its best-selling drug Prograf (tacrolimus) for use in kidney and liver transplants. The new formulation is a modified release version of Prograf, which is used to prevent organ rejection and is currently given twice a day.
The approval for Advagraf is particularly good news for Astellas as it will help soften the blow of Prograf's patent expires in Europe in June 2009. However, the path to approval has not run smooth in the USA, as the Food and Drug Administration issued Astellas with a non-approvable letter for Avagraf in January.