FDA Approves New Indication for Delafloxacin (Baxdela) for CABP

Megan Brooks

November 1, 2019 — Editor's note: This article has been corrected to say that delafloxacin is currently available. (It originally said that delafloxacin's availability was unclear.)

The US Food and Drug Administration (FDA) has approved delafloxacin (Baxdela, Melinta Therapeutics) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria, according to a company news release.

This is the second indication for the fluoroquinolone antibiotic.

The FDA first approved delafloxacin in 2017 for the treatment of adults with acute bacterial skin and skin structure infections caused by designated susceptible bacteria, as reported by Medscape Medical News.

Approval of delafloxacin for CABP was based on positive results from a phase 3, randomized, double-blind trial comparing the efficacy and safety of delafloxacin to moxifloxacin.

In the intent-to-treat population, intravenous-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 compared to IV/oral moxifloxacin (88.9% vs 89.0%).

Delafloxacin also met the FDA secondary endpoint of statistical noninferiority compared to moxifloxacin (90.5% vs 89.7%), based on the investigator's assessment of success at the test of cure visit 5 to 10 days after last dose.

IV-to-oral delafloxacin successfully eradicated key respiratory pathogens at rates comparable to that of moxifloxacin, the company said in its release.

Both IV and oral formulations were well-tolerated, with overall adverse event rates similar between treatment arms. The most common treatment-emergent adverse events with delafloxacin (≥2%) were diarrhea and increases in transaminase levels, which were generally mild and did not lead routinely to treatment discontinuation.

Delafloxacin is currently available in both IV and oral formulations, according to the company. 

Marketing to promote the new indication may be delayed until the company "has greater insight into our ability to secure additional sources of liquidity," notes Jennifer Sanfilippo, Melinta's interim CEO, in the press release.

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