The Menarini Group announced today that on March 6th 2017 it submitted a Marketing Authorization Application for delafloxacin at the European Medicines Agency (EMA) under the trade name Quofenix. The proposed indication for delafloxacin in Europe is the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and the conclusion of the European regulatory process is expected in IIQ 2019.
Delafloxacin (marketed as Baxdela™ in the US) is a novel anionic fluoroquinolone licensed in February 2017 to the Menarini Group from Melinta Therapeutics, Inc., a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections. As part of the development and commercialization agreement, Melinta granted the Menarini Group exclusive rights to commercialize Delafloxacin in 68 countries in Europe, Asia-Pacificincluding China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia.
“The regulatory submission of delafloxacin in Europe, after one year from the signature of the agreement, represents an important strategic milestone for Menarini. ABSSSIs are among the most common human bacterial infections and are associated with considerable morbidity, especially in subjects with underlying diseases. Delafloxacin, with its broad in vitro spectrum of activity against Gram-positive, including methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative and as well as atypical and anaerobe organisms, stands out as a new therapeutic option in this setting. Thanks to this new molecule, we will keep contributing to the health of patients all over the world with the high quality standards that distinguishes Menarini,” says P.Mei General Manager of The Menarini Group .
Delafloxacin offers physicians the flexibility of fixed dose intravenous and/or oral dosage formulations, does not require therapeutic drug monitoring, can be taken with food, has a minimal potential for drug interactions, and does not require therapeutic drug monitoring. These factors, in concert with its favorable safety profile, would support the addition of delafloxacin to the ABSSSI armamentarium as an important treatment option.