The US Food and Drug Administration (FDA) has approved Allecra Therapeutics’ EXBLIFEP (cefepime/enmetazobactam) to treat complicated urinary tract infections (cUTIs) including pyelonephritis.

EXBLIFEP is indicated for patients aged 18 years and above.

The approval is accompanied by a five-year marketing exclusivity extension from the US regulator under the Generating Antibiotic Incentives Now (GAIN) Act.

The GAIN Act offers incentives for developing new anti-infective drugs by granting benefits to qualified infectious disease product manufacturers.

The FDA granted the approval based on comprehensive clinical data highlighting the effectiveness of EXBLIFEP  against antimicrobial resistance in gram-negative bacteria, particularly resistance caused by extended spectrum beta lactamases and ampC enzymes.

The data included results from the Phase III ALLIUM clinical trial in which EXBLIFEP demonstrated superiority to piperacillin/tazobactam in clinical cure and microbiological eradication in cUTI patients.

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Allecra holds an extensive patent estate for the therapy in key markets, with the GAIN Act extending market exclusivity until 2032.

Orchid Pharma discovered enmetazobactam, a component of EXBLIFEP, and assigned all rights outside India to Allecra Therapeutics in 2013.

Since then, Allecra has been solely responsible for the global clinical and regulatory development of EXBLIFEP.

The company has completed exclusive licensing agreements with Shanghai Haini Pharmaceutical in Greater China and ADVANZ PHARMA in Europe.

In another global Phase III trial, EXBLIFEP was analysed against piperacillin / tazobactam, a standard cUTI care, showcasing its potential in a randomised, controlled, double-blind setting.

Allecra’s commercial partner, Advanz Pharma, sought marketing authorisation for EXBLIFEP in Europe.

Allecra Therapeutics supervisory board member Iain Buchanan said: “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small yet highly focused team of individuals.

“As we continue our discussions with strategic partners for product launch in the US, we value the FDA’s positive decision on EXBLIFEP’s ability to address a critical unmet medical need for patients.”