News
Melinta Therapeutics Partner, Menarini Group, Submits Marketing Authorization Application for Delafloxacin in Europe
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that The Menarini Group, Melinta’s commercial and co-development partner, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for delafloxacin (to be marketed under the trade name Quofenix in Europe) for the treatment of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This MAA is based on results of the two Phase 3 PROCEED studies (NCT01811732 and NCT01984684), which met both FDA- and EMA-specified primary endpoints.