Theravance’s NDA for pneumonia drug accepted for filing by FDA

Theravance, a biopharmaceutical company, has announced that the FDA has accepted for filing the new drug application for telavancin, a novel, bactericidal, once-daily injectable investigational antibiotic, for the treatment of nosocomial pneumonia caused by gram-positive bacteria such as methicillin-resistant Staphylococcus aureus.

The telavancin new drug application (NDA) is based on data from two large, multi-center, multinational, double-blind, randomized Phase III clinical studies, Attain 1 and Attain 2, in which 1,503 patients were enrolled and treated, 464 of whom were infected with methicillin-resistant Staphylococcus aureus.

The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in a Prescription Drug User Fee Act date of November 26, 2009.

The NDA filing triggers a milestone payment of $10 million from Theravance’s partner, Astellas Pharma. This is reported to be the second telavancin NDA filed with the FDA, which is currently reviewing telavancin for the treatment of complicated skin and skin structure infections.

Rick Winningham, CEO of Theravance, said: We are very pleased with the FDA’s acceptance of our NDA submission. This is an important potential additional indication for telavancin due to the significant unmet medical need in HAP. Today, there are limited options for physicians treating patients with these serious infections. We look forward to collaborating with the FDA on its review of our NDA.