Allecra Therapeutics receives FDA approval for treatment targeting severe UTIs

The therapy, called EXBLIFEP (cefepime/enmetazobactam), targets UTIs including pyelonephritis, in patients 18 years and older.

"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,” said Iain Buchanan, supervisory board member of Allecra Therapeutics.

“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 U.S., we value the FDA’s positive decision on EXBLIFEP’s ability to address a critical unmet medical need for patients.”

Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).

The GAIN Act, enacted by the U.S. Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs).

The FDA approval was supported by clinical data that demonstrated EXBLIFEP’s effectiveness against antimicrobial resistance in gram-negative bacteria.

This included results from Allecra’s phase 3 ALLIUM trial, which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam.

The news comes after the CHMP (The Committee for Medicinal Products for Human Use) gave the treatment a positive opinion in January 2024.

In addition, the European Medicines Agency (EMA) has also indicated that, in light of results obtained in an epithelial lining fluid penetration study, the company is eligible for approval of cefepime/enmetazobactam for use in hospital-acquired/ventilator-associated bacterial pneumonia.