CHMP recommends Quofenix for the treatment of acute bacterial skin and skin structure infections (ABSSSI).- Menarini

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Quofenix, intended for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents commonly recommended for the initial treatment of these infections. The applicant for this medicinal product is A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Quofenix will be available as 300 mg powder for concentrate for solution for infusion and as a 450 mg tablet. The active substance of Quofenix is delafloxacin, an antibacterial for systemic use (ATC code: J01MA23) which inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), which are enzymes required for bacterial DNA replication, transcription, repair, and recombination.

Delafloxacin given intravenously has been shown to be as effective as vancomycin given intravenously, and delafloxacin given by mouth has been shown to be as effective as vancomycin plus aztreonam given by mouth. The most common side effects are fungal infections, headache, diarrhoea, nausea, vomiting, increase in transaminase levels, itching, and injection/infusion site reactions.