The CHMP has recommended to grant the marketing authorization for Vibativ (telavancin hydrochloride) as a treatment for adults who are suffering from nosocomial pneumonia with ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).
Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby it both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
Discovered and developed by Theravance, Vibativ has been licensed to Astellas for the commercialization of the product.
APEL president and CEO Ken Jones said this positive opinion from the CHMP for Vibativ is great news for both doctors and patients who continue to battle serious life-threatening nosocomial pneumonia, including ventilator-associated pneumonia caused by MRSA.
Theravance SVP and chief commercial officer Leonard Blum said this will be the first approval for VIBATIV for this indication, which is associated with high morbidity and mortality.