Quofenix filed in EU for infectious diseases (ABSSSI).- Melinta Therapeutics.
Melinta Therapeutics 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 III PROCEED studies (NCT01811732 and NCT01984684), which met both FDA- and EMA-specified primary endpoints.
Under a 2017 agreement, Menarini has exclusive rights to commercialize delafloxacin (marketed as Baxdela in the U.S.) in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia. This submission represents the first application by Menarini for regulatory approval in their territory.
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