The FDA approved Exblifep (cefepime/enmetazobactam) based on a comprehensive set of clinical data showing the drug's efficacy against antibiotic resistance in gram-negative bacteria
FDA approves Exblifep for complicated UTI. (Credit: Mufid Majnun on Unsplash)
Allecra Therapeutics has received the US Food and Drug Administration (FDA) approval for its Exblifep (cefepime/enmetazobactam) to treat certain complicated urinary tract infections (cUTIs) patients.
The US FDA has approved Exblifep for cUTIs, including pyelonephritis, in patients aged 18 years and older.
Germany-based Allecra also secured a five-year marketing exclusivity extension as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The move extends extending the company market exclusivity until 2032.
This GAIN Act legislation incentivises the development of new anti-infective treatments.
The FDA approved Exblifep based on a comprehensive set of clinical data showing the drug’s efficacy against antibiotic resistance in gram-negative bacteria.
This data included results from Allecra’s multi-centre, randomised, controlled, double-blind, Phase III ALLIUM study.
It recruited 1,034 patients to receive either cefepime/enmetazobactam (FPE) or piperacillin-tazobactam (PTZ), the current standard of care, through intravenous infusion.
The trial met its primary endpoint with FPE significantly outperforming PTZ in the composite success result of clinical cure and microbiological eradication at the test-of-cure visit.
FPE was well tolerated and appeared to have a similar safety profile to PTZ with 4.3% of patients reporting significant adverse events in the trial, compared to 3.7% with PTZ.
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.
“I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process.
“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.”
Enmetazobactam was first discovered by Orchid Pharma and in 2013. Allecra Therapeutics was granted full rights for the drug outside of India.
Since then, the German biopharmaceutical business has assumed full responsibility for Exblifep’s worldwide clinical and regulatory development.
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