Melinta Therapeutics Inc (NASDAQ:MLNT) stock rocketed Wednesday after it revealed the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for BAXDELA (delafloxacin) for priority review.
The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP), which refers to pneumonia contracted by a person with little contact with the health care system.
CAPB is the most common type of pneumonia, and a leading cause of illness and death.
Shares in the New Haven, Connecticut, pharma company more than doubled to $4.43.
The FDA granted priority review status to BAXDELA based on the previous Qualified Infectious Disease Product designation the drug enjoys, which offers incentives to drug makers to develop antibacterial and antifungal treatments for life threatening infections.
Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date, or proposed review deadline date of October 24.
"Due to the rise of antibiotic resistance and an aging population, community-acquired bacterial pneumonia, remains a challenge for healthcare professionals and has led to a need for new treatment options,” said Sue Cammarata, chief medical officer at Melinta Therapeutics.
Cammarata said BAXDELA’s potency against the most common bacterial pathogens seen in CABP show it could play a “significant role” in the treatment of this illness, if approved.
“We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible,” said Cammarata.
The sNDA application is based on positive results from a Phase III, randomized, double-blind, study that compared the potency and safety of BAXDELA to moxifloxacin for the treatment of CABP.
The study results showed that BAXDELA had comparable efficacy to moxifloxacin for early clinical response. Additionally, BAXDELA was generally safe and well-tolerated. The company said results from this study will be submitted for presentation at an upcoming medical conference.
BAXDELA (delafloxacin) tablets and intravenous injection were approved by the FDA in 2017 for treating acute bacterial skin and skin structure infections.
Contact Uttara Choudhury at [email protected]