The Medicines Company says it's no longer seeking EMEA approval to market its investigational antibiotic, oritavancin, after the agency indicated that it would need additional data before considering approval. The application was filed in June 2008 by Targanta Therapeutics, which Medicines Co. acquired earlier this year.
Oritavancin is designed to treat skin and skin structure infections. The FDA issued a complete response letter to Targanta's NDA for the drug candidate last December, and also raised questions about the safety of the drug. Targanta cut its workforce by 75 percent following the FDA's rejection.
Medicines Co. said it is in discussions with the FDA, and will consult the EMEA as well, on the design of a new global Phase III trial. The drugmaker expects to start the trial later this year.
- here's the release