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