Astellas Pharma and partner Theravance are celebrating the thumbs-up for their antibiotic Vibativ by regulators in the USA.

The US Food and Drug Administration has approved Vibativ (telavancin) for the treatment of adults with complicated skin and skin structure infections caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both MRSA and MSSA strains. The approval of the bactericidal, once-daily injectable lipoglycopeptide, which was discovered by Theravance, is based on two Phase III clinical studies, ATLAS 1 and ATLAS 2.

Those trials involved 1,867 patients, 719 of whom had infections with MRSA. Telavancin achieved its primary endpoint of non-inferiority against the standard of care, vancomycin, in both studies, Astellas and Theravance said.

Rick Winningham, Theravance’s chief executive, said that the approval “is a significant event that marks the first approved indication for Vibativ” and validates his firm’s strategies in drug discovery and development. The treatment will be sold by Astellas and is expected to be available in the USA during the fourth quarter, while Theravance will co-marketing for the first three years following approval.