Melinta Therapeutics reports that The Menarini Group, Melinta’s commercial and co-development partner, has submitted a Marketing Authorization Application 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.

“This is an important milestone for Melinta, and if approved would represent a significant expansion of delafloxacin’s market reach,” stated Dan Wechsler, Melinta’s president and chief executive officer. “In clinical studies, delafloxacin demonstrated potent activity across a broad range of pathogens. The ability to treat infections including those caused by methicillin-resistant Staphylococcus aureus with an IV or oral option should resonate with regulatory bodies and healthcare providers alike.”