Astellas has won approval in Europe for Vibativ, an injectable antibacterial drug, as a treatment for hospital-acquired pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA).
This is a rare approval for a new antibiotic and answers a pressing need for new drugs to treat resistant bacterial infections. This is the first approval for Vibativ (telavancin) in hospital-acquired pneumonia, an infection which is associated with high morbidity and mortality.
The EU approval has been granted for the treatment of adult patients with hospital-acquired pneumonia, including ventilator-associated pneumonia, which is known or suspected to be caused by MRSA when other alternatives are not suitable.
The drug as originally discovered by US company Theravance, with worldwide commercialisation rights licensed to Astellas in 2005. It is a once-daily, bactericidal lipoglycopeptide antibiotic with a dual mechanism of action, inhibiting bacterial cell wall synthesis whilst also disrupting bacterial cell membrane function.
The US Food and Drug Administration cleared Vibativ for the treatment of complicated skin and skin structure infections (cSSI) caused by MRSA and methicillin-susceptible Staphylococcus aureus in 2009, but asked for more data before it could approve it for hospital-acquired pneumonia.
In its latest quarterly report, the company said that the likelihood of winning US approval for the latter indication is low. The drug is also approved in Canada for cSSI.
Last year, Decision Resources said that it expected sales of telavancin to be fairly modest given the lack of a pneumonia indication in the USA, and it cut its forecast for 2018 sales in the major markets of the USA, France, Germany, Italy, Spain, the UK and Japan from $140 million to $55 million.In a statement, Astellas said launch plans in Europe were "under review."