Theravance submits application for antibiotic

In two phase III studies telavancin achieved its primary endpoint of non-inferiority in both studies. Telavancin compared favorably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections.

“If approved, telavancin can become an important new medicine in the treatment of resistant gram-positive infections, especially MRSA infections, which are increasing in prevalence,” said Michael Kitt, vice president of Development at Theravance.

“Telavancin’s unique mechanism of action involves inhibition of bacterial cell wall synthesis as well as disruption of the functional integrity of the bacterial cell membrane.”

Theravance’s telavancin program focusing on treating serious gram-positive bacterial infections is a joint project with Astellas Pharma.