MLNT
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U.S. Food and Drug Administration (FDA) 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).
The FDA granted priority review status based on the previous Qualified
Infectious Disease Product (QIDP) designation, which provides certain
incentives for the development of antibacterial and antifungal treatments for
serious or 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.
"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,”
said Sue Cammarata, M.D., chief medical officer of Melinta. "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. We look forward to working with the FDA
to help evaluate bringing this potential option to people with CABP as soon as
possible.”
The sNDA application is based on positive results from a Phase III,
randomized, double-blind, study that compared the efficacy 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 and clinical outcome at test of cure. Additionally, BAXDELA was
generally safe and well-tolerated. Detailed efficacy and safety results from
this study will be submitted for presentation at an upcoming medical
conference.
BAXDELA was approved by the FDA in 2017 for the treatment of adult patients
with acute bacterial skin and skin structure infections (ABSSSI) caused by
designated susceptible bacteria.
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