The Food and Drug Administration has accepted a supplemental New Drug Application for pneumonia drug Baxdela.
Baxdela, or delafloxacin, comes from Melinta Therapeutics, Inc. Its new priority review status from the FDA could expand treatment to include Baxdela for adult patients with community-acquired bacterial pneumonia.
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The drug was first approved by the agency in 2017 to treat adult patients with acute bacterial skin and skin structure infections caused by susceptible bacteria.
"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," Sue Cammarata, chief medical officer of Melinta, 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."
The FDA’s sNDA for Baxdela is based on quality results from a study comparing the drug to another medication called moxifloxacin, which is also used to treat bacterial infections. Researchers found Baxdela had “comparable efficacy” for clinical response and outcome.
According to a press release from Melinta Therapeutics, the FDA has assigned a proposed review deadline of Oct. 24, 2019, to collect fees from drug manufacturers to fund the new approval process.
Shares of Melina Therapeutics more than doubled after the company's announcement Wednesday.
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