QUOFENIX (delafloxacine)

The Committee deems that the clinical benefit of QUOFENIX (delafloxacin) is substantial only in the treatment of severe, microbiologically documented, polymicrobial including MRSA, delafloxacin-susceptible acute bacterial skin and skin structure infections (ABSSSI), and only as second-line treatment, i.e., when it is considered inappropriate to use other antibacterial agents that are commonly recommended as first-line treatment of these infections, in particular for reasons related to resistance, safety, allergy or administration method;

Considering:

• its activity against Gram-negative and Gram-positive bacteria, in particular methicillin-resistant Staphylococcus,
• the simplification of the administration regimen (monotherapy active against Gram-positive and negative bacteria),
• the demonstrated non-inferiority of delafloxacin IV compared to vancomycin/aztreonam IV on the clinical recovery rate at the follow-up visit (EMA primary endpoint) in patients with mild to moderate skin or skin structure infection;

 but considering:

• inadequate documentation of its clinical efficacy in severe skin infections and/or those due to multi-drug resistant bacteria,
• concerns about its safety profile in view of the known adverse effects (including tendinopathy and peripheral neuropathy) of fluoroquinolone antibiotics,
• the absence of demonstration of the non-inferiority of delafloxacin (IV then oral) versus vancomycin/aztreonam IV dual therapy, not formally supporting the clinical value of the oral form despite its value for patients,

the Committee considers that QUOFENIX (delafloxacin) provides no clinical added value (CAV V) in the treatment of severe, microbiologically documented, polymicrobial including MRSA acute bacterial skin and skin structure infections (ABSSSI) and as second-line treatment.