Health Canada clears Astellas/Theravance's Vibativ for cSSSI indications

Drug industry regulator Health Canada has approved Astellas Pharma Canada, a unit of the like-named Japanese drug major, and Theravance's Vibativ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.

This is the second approval for Vibativ this year, following the approval in September by the US Food and Drug Administration (The Pharma Letter September 14).

"We believe VIBATIV can make important contributions to the ongoing fight against microbial resistance," said Fumiaki Sakurai, president of Astellas Pharma Canada.

"The approval of Vibativ in Canada and the recent approval in the USA focus attention on the urgent need for new antibiotics to treat Gram-positive infections caused by MRSA," added Rick Winningham, chief executive of Theravance

Vibativ will be marketed and sold by Astellas and is expected to be commercially available in Canada in early 2010.