Theravance, Inc announced that the US Food & Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for telavancin, a novel, bactericidal, once-daily injectable investigational antibiotic, for the treatment of nosocomial pneumonia (also known as hospital-acquired pneumonia, or HAP) caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in a Prescription Drug User Fee Act (PDUFA) date of November 26, 2009. The NDA filing triggers a milestone payment of $10 million from Theravance's partner, Astellas Pharma Inc. This is the second telavancin NDA filed with the FDA, which is currently reviewing telavancin for the treatment of complicated skin and skin structure infections (cSSSI).
"We are very pleased with the FDA's acceptance of our NDA submission," said Rick E Winningham, Theravance's Chief Executive Officer. "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."
Telavancin is a bactericidal, once-daily injectable investigational antibiotic with a multifunctional mechanism of action. Telavancin was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus, including MRSA, and other Gram-positive bacteria.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction.