Japan’s Astellas Pharma has submitted a marketing authorisationapplication to the EMEA for telavancin, a rapidly bactericidalinjectable antibiotic developed by US partner Theravance.
Astellas has filed telavancin, which it says has a uniquemultifunctional mechanism of action, for treatment of complicated skinand soft tissue infections in adults. The application is based on twodouble-blind, randomised phase III clinical studies (ATLAS 1 and ATLAS2) that enrolled and treated 1,867 patients, 719 of whom had infectionswith methicillin-resistant Staphylococcus aureus.
According to an Astellas spokesman, telavancin achieved its primaryendpoint of non-inferiority in both studies, and the compound comparedfavourably to standard therapy in clinical cure, microbiologicaleradication, and overall therapeutic response rates. Its safety profilewas compatible with treatment of patients with serious infections. Thefirm filed a new drug application in the USA for telavancin in Februarythis year.
The telavancin submission came shortly afterAstellas said it had received European approval to market Advagraf®, aonce-daily version of its best-selling drug Prograf® (tacrolimus) foruse in kidney and liver transplants. The new formulation is amodified-release version of Prograf, which is used to prevent organrejection and is currently given twice a day.