Melinta Therapeutics announced Monday that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA).
Melinta’s NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684), in both of which Baxdela met the primary endpoint of non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size at the primary infection site at 48-to-72 hours.
In addition, Baxdela met the primary endpoint, the investigator assessment of clinical cure, for the European Medicines Agency (EMA) in both studies. Baxdela was shown to be well tolerated among Phase 3 study participants, with less than 1% of patients discontinuing for treatment-related adverse events.
“Baxdela, if approved, represents a potentially attractive treatment option for the nearly 3 million patients hospitalized annually in the U.S. with serious skin infections,” stated Eugene Sun, M.D., Melinta’s Chief Executive Officer. “These patients have a high rate of treatment failure, and frequently have underlying medical conditions that pose challenges to the choice of antibiotic. Baxdela has been tested in over 2,600 patients to date, and was well-tolerated with fewer than 1% of Baxdela-treated patients discontinuing due to treatment-related adverse events.”
Baxdela has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. FDA, which provides for priority review. Melinta therefore could receive a regulatory decision by mid-year 2017 consistent with Prescription Drug User Fee Act (PDUFA) priority review timelines.
“Baxdela has demonstrated in clinical trials a broad spectrum of activity and the ability to treat patients with serious co-morbidities, both of which are compelling characteristics sought by physicians according to our market research. We believe that Baxdela’s ability to treat challenging patients in hospitals will be a major driver of adoption,” concluded John Temperato, Melinta’s President and Chief Operating Officer. “If approved, we plan to support the introduction of Baxdela for the treatment of ABSSSI with a focused acute-care hospital sales force. We believe we can further leverage the resources of such a sales team in the future as we seek to complete clinical studies and file applications to market Baxdela in additional indications such as community-acquired bacterial pneumonia and complicated urinary tract infections.”
Baxdela (delafloxacin) is an investigational anionic fluoroquinolone antibiotic for hospital-treated skin infections, known as acute bacterial skin and skin structure infections (ABSSSI). Baxdela has robust in-vitro antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA), a major cause of hospital-treated skin infections, a favorable tolerability profile, and both intravenous and oral dosage forms, which may facilitate hospital discharge.