Astellas, Theravance Gain Vibativ MA

Astellas Pharma Europe Ltd. and Theravance received marketing authorization from the European Commission for Vibativ (telavancin hydrochloride). Vibativ was discovered by Theravance and is a bactericidal, once-daily injectable lipoglycopeptide antibacterial agent with a dual mechanism of action against Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).

The marketing authorization is for the treatment of adults with nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. Launch plans are under review by Astellas.
“The approval of Vibativ can provide European healthcare professionals with a new, effective hospital antibiotic option for patients with hospital-acquired pneumonia caused by MRSA,” said Ken Jones, president and chief executive officer of Astellas Pharma Europe.

“We are extremely excited about the European approval of Vibativ for the treatment of nosocomial pneumonia caused by MRSA,” said Rick E Winningham, Theravance’s chief executive officer. “This is a significant milestone for the collaboration, marking the first approval for this indication. I believe Vibativ will be a valuable new therapy option for physicians in Europe treating this life-threatening infection.”