Menarini files for delafloxacin approval in Europe

Family-controlled Italian drugmaker Menarini Group has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency 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.

In March 2017, Menarini acquired exclusive rights from USA-based Melinta Therapeutics (Nasdaq: MLNT) to commercialize delafloxacin (marketed as Baxdela in the USA) 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 its territory.