The US Food and Drug Administration (FDA) has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) to treat complicated urinary tract infections (cUTIs).
The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria.
UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all healthcare-associated infections, cUTIs have an increased likelihood of complications such as treatment failure and persistent or recurrent infection.
The FDA’s decision was supported by clinical data demonstrating Exblifep’s effectiveness against antimicrobial resistance (AMR) in gram-negative bacteria.
This included results from the late-stage ALLIUM trial, which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam, a current standard of care, in the primary composite endpoint of clinical cure and microbiological eradication.
Designated by the World Health Organization as one of the top ten threats to global public health, AMR develops when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time, making them more resistant to treatment.
Alongside the approval, Allecra has received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act, which incentivises the creation of new anti-infective therapeutics by providing benefits to manufacturers.
Iain Buchanan, supervisory board member of Allecra, described the approval as a “tremendous achievement” for Allecra.
He continued: “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 all rights outside India were assigned in 2013 to Allecra, which has since taken sole responsibility for the international clinical and regulatory development of Exblifep.
In Europe, Advanz Pharma has licensed the combination, which received a recommendation from the European Medicines Agency’s human medicines committee in January.
The Committee for Medicinal Products for Human Use’s recommendation includes the intravenous use of Exblifep to treat adults with cUTIs, hospital-acquired and ventilator-associated pneumonia, and patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed.