FDA Approves Allecra’s Exblifep for Urinary Tract Infections, Rejects Venatorx and Melinta’s Treatment

In recent developments, the FDA has greenlighted one antibiotic combination therapy for complicated urinary tract infections (cUTIs) while rejecting another. Venatorx Pharmaceuticals and Melinta Therapeutics faced disappointment last week as the FDA declined their antibiotic combination treatment, cefepime/taniborbactam, for the same indication.

Allecra Therapeutics celebrates FDA approval for Exblifep (cefepime/enmatazobactam) as a viable treatment option for cUTIs, including the severe kidney ailment pyelonephritis, triggered by gram-negative bacteria.

The FDA’s endorsement of Exblifep includes an added perk for Allecra—a five-year prolongation of market exclusivity through the Generating Antibiotic Incentives Now (GAIN) Act until 2032. This legislation is designed to incentivize the manufacturing of new anti-infective treatments by providing certain advanatges to manufacturers of Qualified Infectious Disease Products (QIDPs).

Orchid Pharma’s discovery of enmatazobactam led to the establishment of Allecra in 2013, tasked with developing the extended-spectrum beta-lactamase inhibitor (BLI) outside of India. Cefepime, originating from Bristol Myers Squibb and approved in 1994, is a beta-lactam antibiotic. Despite its historical significance, cefepime faced a setback when it was removed from the World Health Organization’s essential medicines list in 2019 due to diminishing effectiveness.

The FDA’s decision was supported by a phase 3 trial demonstrating the superiority of cefepime/enmatazobactam over the standard treatment, piperacillin/tazobactam, in terms of clinical cure rates and microbiological eradication.

Allecra has inked licensing deals for Exblifep with Advanz Pharma in Europe and Shanghai Haini Pharmaceutical in China. Regarding the complete response letter (CRL) sent to Venatorx and Melinta by the FDA, while no clinical safety or efficacy issues were raised, a manufacturing problem was identified.

Last month, the Committee for Medicinal Products for Human Use (CHMP) in Europe provided a positive assessment of cefepime/enmatazobactam. 

Additionally, the European Medicines Agency (EMA) signaled the combination’s suitability for approval in addressing hospital-acquired ventilator-associated bacterial pneumonia.

Funding for the development of the combination therapy by Venatorx and Melinta is being provided by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the Department of Health and Human Services, and the Biomedical Advanced Research and Development Authority.

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