New Treatment for CABP Receives FDA Approval
Officials with the FDA have expanded the use of Melinta Therapeutics’ delafloxacin (Baxdela) to include treatment of adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria, but the drug’s availability will be delayed for this new indication.
Officials with the FDA have expanded the use of Melinta Therapeutics’ delafloxacin (Baxdela) to include treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. However, the drug’s availability will be delayed for this new indication.
Melinta’s delafloxacin was previously 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.
The approval of delafloxacin’s new indication is based on positive results from a phase III, randomized, double-blind, study that compared the efficacy and safety of the drug to moxifloxacin.
The study results demonstrated that delafloxacin met all key primary and secondary endpoints in the trial, according to Melinta. In the intent-to-treat population (ITT), IV-to-oral delafloxacin met the FDA primary endpoint of statistical noninferiority for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in delafloxacin patients) compared to IV/oral moxifloxacin (89.0%).
Delafloxacin also met the FDA secondary endpoint of statistical noninferiority (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 delafloxacin successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin.
Both intravenous (IV) and oral delafloxacin were well-tolerated among study participants. Overall adverse event rates were similar between treatment arms. The most common treatment-emergent adverse events in the delafloxacin arm (≥ 2%) were diarrhea and transaminase increases, which were generally mild.
The new supplemental approval for delafloxacin follows FDA priority review that is 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.
In a prepared statement, Jennifer Sanfilippo, interim chief executive officer of Melinta, said that although the company believes that delafloxacin has the potential to play a significant role in treating CABP, the company is delaying the commercial launch in order to achieve greater insight into its liquidity position.
Melinta Therapeutics Announces U.S. FDA Approval of Supplemental New Drug Application for BAXDELA® (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) [news release]. Morristown, NJ; October 24, 2019: Melinta Therapeutics. [email]. Accessed October 25, 2019.