The Menarini Group sought European Medicines Agency approval for delafloxacin to treat adults with acute bacterial skin and skin structure infections.
In 2017, Italian drugmaker Menarini obtained the exclusive rights to commercialize the treatment from New Haven, Conn.-based biopharmaceutical company Melinta Therapeutics Inc.
Menarini plans to commercialize the medicine, known as Baxdela in the U.S., as Quofenix in Europe.
The application is based on results of two phase 3 studies, which met both primary goals specified by the EMA and the U.S. Food and Drug Administration.
