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FDA accepts Melinta Therapeutics sNDA for pneumonia drug

The FDA has accepted Melinta Therapeutics’ (NASDAQ:MLNT) supplemental NDA (sNDA) for BAXELDA for the treatment of community-acquired bacterial pneumonia (CABP).

BAXDELA, or delafloxacin, was approved by the FDA in 2017 for the treatment of acute bacterial skin and skin structure infections. Melinta submitted this sNDA application based on positive results from a Phase 3 trial that demonstrated that BAXDELA had comparable efficacy to moxifloxacin, one of the standard treatments for CABP.

“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,” Dr. Sue Cammarata, Melinta’s CMO, said in a statement.

“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,” she added.

The FDA has assigned BAXDELA a PDUFA action date of October 24, 2019.

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