pharmaphorum February 27, 2024
The FDA has approved Allecra Therapeutics’ Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.
The FDA has given the green light to Exblifep, based on long-established beta-lactam antibiotic cefepime and a new extended-spectrum beta-lactamase inhibitor (BLI) called enmetazobactam, for the treatment of cUTIs in adults, including severe kidney infections (acute pyelonephritis) caused by susceptible Gram-negative organisms.
Venatorx Pharmaceuticals and partner Melinta Therapeutics were not so fortunate with their application for cefepime with BLI taniborbactam in the same indication, getting a complete response letter (CRL) from the regulator with a request for more information on chemistry, manufacturing, and controls (CMC) for the drug.
Cefepime...
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