Commercial launch suspended due to manufacturer liquidity.
The FDA has approved an indication expansion for delafloxacin (Baxdela, Melinta Therapeutics) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.
Delafloxacin is a fluoroquinolone antibacterial IV injection first approved by the FDA in 2017 for the treatment of active bacterial skin and skin structure infections.
The approval is based upon the results of a phase 3, randomized, double-blind study in which delafloxacin exhibited non-inferiority compared to moxifloxacin. In the study’s primary endpoint (early clinical response), patients receiving delafloxacin exhibited signs at 96 hours after ignition therapy. In the study’s secondary endpoint (success at test of curve visit 5 to 10 days after the last dose), patients receiving delafloxacin showed a non-inferior 90.5% success rate compared to the moxifloxacin group (89.7%).
Data from the study also show that delafloxacin IV/oral successfully eradicated key respiratory pathogens at rates similar to moxifloxacin and was well-tolerated among the study participants. The most common adverse events reported throughout the clinical trial include diarrhea and transaminase increases, though neither required discontinuation of treatment.
Trending: FDA Warns of Cough Syrup Contamination
“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 in a statement. “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.”
Delafloxacin is contraindicated in patients with a known hypersensitivity to the product or other fluoroquinolones.
Boxed warnings issued with delafloxacin say fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions including tendinitis and tenon rupture; peripheral neuropathy; and central nervous system effects. Providers should discontinue treatment immediately and avoid use of fluoroquinolones or delafloxacin in patients who experience these side effects. Fluoroquinolones and delafloxacin may also exacerbate muscle weakness in patients with myasthenia gravis.
Aside from hypersensitivity reactions, delafloxacin also comes with a warning of Clostridium difficile-associated diarrhea that may occur with treatment.
Other adverse events reported with the use of delafloxacin include nausea, diarrhea, headache, transaminase elevations, and vomiting.