Melinta Therapeutics Provides Baxdela NDA Update

Melinta Therapeutics, a privately held company focused on developing novel antibiotics to treat serious bacterial infections, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company, as part of its mid-cycle review process, that it does not currently plan to hold an Advisory Committee meeting for Melinta’s New Drug Applications (NDAs) for Baxdela™ (delafloxacin). Baxdela™ is an investigational fluoroquinolone with first-in-class activity against MRSA (methicillin-resistant Staphylococcus aureus). The NDAs for Baxdela™, which has been granted QIDP (Qualified Infectious Disease Product) status, are under priority review by the FDA for serious skin infections, following successful completion of two Phase 3 studies comparing Baxdela™ monotherapy with the combination of vancomycin plus aztreonam.