Theravance (THRX) and Astellas Pharma have won FDA approval of telavancin to fight MRSA-related skin infections. And the decision triggers a $20 million milestone payment for Theravance.
This is the first regulatory win for Theravance in its 12-year history, notes the San Francisco Business Times. It's also a notable achievement in healthcare. Telavancin will be jointly marketed in the U.S. as Vibativ for three years. And Theravance stands to gain an additional $10 million milestone in November if telavancin is approved for hospital-acquired pneumonia.
"Vibativ has demonstrated its efficacy and safety in clinical trials for the treatment of Gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date," said Ralph Corey, M.D., professor of medicine at the Duke University Medical Center and the principal investigator in the ATLAS program. The drug will be commercially available later this year.
- check out the press release
- check out the story from the San Francisco Business Times
Editor's Note: When this story originally appeared it included a note that telavancin is the first therapy approved specifically for MRSA. A spokesperson from Pfizer tells FierceBiotech that Zyvox (linezolid) was FDA approved in 2000 for the treatment of complicated skin and skin structure infections caused by MRSA.