MALVERN, PA — Venatorx Pharmaceuticals and Melinta Therapeutics recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning their New Drug Application (NDA) for cefepime-taniborbactam. The antibiotic combination is under review as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis caused by susceptible gram-negative microorganisms.
The FDA’s response did not raise concerns about clinical safety or efficacy; nor did it request any new clinical trials to support the approval of cefepime-taniborbactam. Instead, the agency asked for additional chemistry, manufacturing, and controls (CMC) data related to the drug’s production and testing methods.
Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx, expressed disappointment at this delay but reaffirmed faith in cefepime-taniborbactam. He assured that they’re diligently addressing the FDA’s requests for additional CMC data and committed to working closely with the agency to expedite the drug’s availability.
Melinta’s CEO and President, Christine Ann Miller, also voiced her commitment to supporting the US commercialization of this drug. She expressed belief in the potential of cefepime-taniborbactam to provide an essential therapy for adult patients dealing with complicated urinary tract infections, including acute pyelonephritis caused by susceptible gram-negative microorganisms.
Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic combination being developed for treating cUTIs, including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
The drug combination involves cefepime, a widely used beta-lactam (BL) antibiotic with over two decades of proven safety and effectiveness against susceptible gram-negative and gram-positive bacteria, and taniborbactam, a beta-lactamase inhibitor (BLI). Together, they’re being studied as a potential treatment option for serious bacterial infections caused by antibiotic-resistant gram-negative bacteria, including Extended Spectrum Beta-lactamase (ESBL)-expressing Enterobacterales, carbapenem-resistant Enterobacterales (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa (MDR-PA), which can include carbapenem-resistant P. aeruginosa (CRPA).
The FDA granted cefepime-taniborbactam both Qualified Infectious Disease Product (QIDP) and Fast Track designations. The latter is designed to facilitate the development and expedite the review of drugs to treat serious conditions lacking sufficient treatment options. The QIDP designation provides incentives for developing new antibiotics, including priority review and a five-year extension of regulatory exclusivity. This designation, authorized under the Generating Antibiotic Incentives Now (GAIN) Act of 2012, highlights the urgency in the development of new antibiotics.
Despite the recent setback, Venatorx and Melinta remain committed to making cefepime-taniborbactam available to patients as quickly as possible. Their response to the CRL will be closely watched by industry observers, as the approval of this drug could mark a significant advancement in the treatment of severe bacterial infections caused by antibiotic-resistant gram-negative bacteria.
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