The Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) for Baxdela (delafloxacin; Melinta Therapeutics, Inc) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP).
The sNDA is supported by data from the phase 3, double blind, DEFINE-CABP trial (N=860) which compared the safety and efficacy of Baxdela to moxifloxacin for the treatment of CABP. Patients were randomized to receive either Baxdela 300mg IV every 12 hours (for at least 6 doses) or moxifloxacin 400mg IV every 24 hours (for at least 3 doses) with potential to switch to the oral formulation. The primary endpoint was early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening in the other symptoms in the intent-to-treat population.
Results showed comparable efficacy between Baxdela and moxifloxacin for early clinical response and clinical outcome at test of cure (secondary endpoint). Moreover, Baxdela was found to be safe and well-tolerated. The full study results will be submitted for presentation at an upcoming medical conference. A Prescription Drug User Fee Act (PDUFA) date of October 24, 2019 has been set for the sNDA.
“Baxdela’s potency and activity against the most common bacterial pathogens seen in CABP indicate it could play a significant role in the treatment of this life-threatening illness, if approved,” said Sue Cammarata, MD, chief medical officer of Melinta. “We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.”
Baxdela, a fluoroquinolone antibiotic, is currently indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of gram-positive and gram-negative organisms.
The product is supplied as a sterile, lyophilized powder in 300mg single-dose vials. The oral tablets are available in a 450mg strength in 20-count bottles. The 450mg tablet is bioequivalent to, and interchangeable with, the 300mg IV dose.
For more information visit baxdela.com.