The Medicines Company has withdrawn the European marketing authorization application (MAA) for the 200mg, 3-7 day daily dose therapy of oritavancin. Oritavancin is an investigational antibiotic drug candidate for the treatment of complicated skin and skin structure infections (cSSSI), caused by gram positive pathogens.
Reportedly, the MAA was filed in Europe in June 2008, by Targanta. During their review of the MAA this year, the European Medicines Agency (EMEA) expressed concerns similar to those raised by the FDA in their complete response letter, issued December 2008, to Targanta’s new drug application for oritavancin.
The feedback from both agencies indicated that another trial would be required before approval could be considered. The Medicines Company has formally notified the EMEA of its decision to withdraw its MAA for the 200mg daily dose of oritavancin.