16. September 2011 15:53
Astellas has received EU approval for Vibativ, an injectable antibacterial drug to treat pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA).
This rare approval for a new antibiotic answers the pressing need for drugs to treat resistant bacterial infections.
Rick E Winningham, CEO of US company Theravance, original owner of the rights of Vibativ, said: “We believe that Vibativ will become an important medicine addressing the urgent medical need for new antibiotics to treat Gram-positive infections caused by MRSA”.
The telavancin drug is indicated for the treatment of adults with hospital-acquired pneumonia, including ventilator-associated pneumonia.
The FDA previously approved Vibativ in the US for the treatment of complicated skin and skin structure infections (cSSI) caused by MRSA in 2009, but asked for more data before clearing its use to treat hospital-acquired pneumonia.
In a statement, Astellas said that plans to launch in Europe were “under review.”