FDA approves delafloxacin for specific cases of community-acquired bacterial pneumonia

The U.S. Food and Drug Administration (FDA) has approved BAXDELA® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. The approval has been granted to Melinta Therapeutics.This is the second indication for the fluoroquinolone antibiotic.

Delafloxacin 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.

This supplemental approval follows Food and Drug Administration priority review 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.

"We are pleased to announce the approval of BAXDELA for the treatment of CABP in adults," said Jennifer Sanfilippo, interim chief executive officer of Melinta. "As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives. As such, while we believe that BAXDELA will play a significant role in the treatment of this potentially life-threatening illness, we are delaying the commercial launch of CABP until we have greater insight into our ability to secure additional sources of liquidity."

The Food and Drug Administration approval of Delafloxacin for the treatment of CABP is based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of BAXDELA to moxifloxacin. The study results demonstrated that BAXDELA met all key primary and secondary endpoints in the trial. In the intent-to-treat population (ITT), IV-to-oral BAXDELA met the FDA primary endpoint of statistical non-inferiority for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in BAXDELA patients) compared to IV/oral moxifloxacin (89.0%).

Delafloxacin also met the Food and Drug Administration secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator's assessment of Success at the Test of Cure visit (5-10 days after last dose) in the ITT population. Data further showed that IV/oral BAXDELA successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin. Both intravenous (IV) and oral BAXDELA were well-tolerated among study participants. Overall adverse event rates were similar between treatment arms. The most common treatment-emergent adverse events in the BAXDELA arm (≥ 2%) were diarrhea and transaminase increases, which were generally mild and did not lead routinely to treatment discontinuation.

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