Wyeth withdraws US CAP Tygacil application

US drug major Wyeth has withdrawn its application to expand the European indication for Tygacil (tigecycline) to include pneumonia because the data package did not include enough severely ill patients.

The antibiotic was first cleared in the European Union in April 2006 and is currently used for complicated skin and soft-tissue infections and complicated intra-abdominal infections. In 2007, Wyeth submitted an application to extend the authorized indications to include community-acquired pneumonia (Marketletter October 29, 2007). At the time of the withdrawal, the application was under review by the European Medicine Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).