Melinta Therapeutics files Baxdela NDAs for hospital-treated skin infections

Privately-held US antibiotics developer Melinta Therapeutics has submitted New Drug Applications (NDAs) to the US Food and Drug Administration 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 III 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 in both studies. Baxdela was shown to be well tolerated among Phase III 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, Melinta’s chief executive. “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,” he noted.

FDA decision likely mid-2017