The sNDA application is based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of BAXDELA to moxifloxacin for the treatment of CABP.
The following press release was posted by Melinta Therapeutics.
Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for BAXDELA® (delafloxacin) for priority review. The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP).
The FDA granted priority review status based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019.
"Due to the rise of antibiotic resistance and an aging population, community-acquired bacterial pneumonia, or CABP, remains a challenge for healthcare professionals and has led to a need for new treatment options,” said Sue Cammarata, M.D., chief medical officer of Melinta. "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. We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.”
The sNDA application is based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of BAXDELA to moxifloxacin for the treatment of CABP. The study results showed that BAXDELA had comparable efficacy to moxifloxacin for early clinical response and clinical outcome at test of cure. Additionally, BAXDELA was generally safe and well-tolerated. Detailed efficacy and safety results from this study will be submitted for presentation at an upcoming medical conference.
BAXDELA was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.