Delafloxacin gets FDA priority review approval for community-acquired bacterial pneumonia

The U.S Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for BAXDELA^® (delafloxacin) for priority review. The Food and Drug Administration has received sNDA to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP).

Due to the rise of antibiotic resistance and an ageing population, community-acquired bacterial pneumonia, or CABP, remains a challenge for healthcare professionals and keeping in view of increasing challenge of bacterial resistance Food and Drug Administration has accepted a priority review request.

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 the 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.

"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 Food and Drug Administration,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. BAXDELA comes in tablet form as well as an intravenous injection. The drug is marketed by Melinta Therapeutics.

BAXDELA was approved by the Food and Drug Administration in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.

The FDA approval in 2017 was based on its efficacy against both gram-positive and gram-negative pathogens, including MRSA. It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies BAXDELA for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.

BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis; Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.