One up, one down: Allecra scores FDA nod for antibiotic combo after Venatorx hit with rejection

Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another.

The United States regulator has signed off on Allecra Therapeutics’ Exblifep (cefepime/enmatazobactam) as a treatment for cUTIs, including the severe kidney condition pyelonephritis, brought on by gram-negative bacteria.

Meanwhile, the FDA handed out a rejection last week in the same indication for Venatorx Pharmaceuticals and Melinta Therapeutics’ antibiotic combo treatment cefepime/taniborbactam.

As part of the approval, the FDA has extended Allecra five years of additional market exclusivity as part of the Generating Antibiotic Incentives Now (GAIN) Act. That exclusivity now will run through 2032, the company said. GAIN incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of qualified infectious disease products (QIDPs).

Orchid Pharma, which discovered enmatazobactam, established Allecra in 2013 to take on development of the extended-spectrum beta-lactamase inhibitor (BLI) outside of India. Cefepime, which was developed by Bristol Myers Squibb and approved in 1994, is a beta-lactam antibiotic. Because of its increasing ineffectiveness, cefepime was removed from the World Health Organization’s list of essential medicines in 2019.

“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,” Iain Buchanan, Allecra’s supervisory board member, said in a release.

The approval was backed by a phase 3 trial which showed the superiority of cefepime/enmatazobactam to the standard of care, piperacillin/tazobactam, in clinical cure rates and microbiological eradication.   

In January, Europe’s Committee of Medicinal Products for Human Use (CHMP) provided a positive opinion on cefepime/enmatazobactam. Additionally, the European Medicines Agency (EMA) said that the combo is eligible for approval for use in hospital-acquired ventilator-associated bacterial pneumonia.

Allecra has signed license agreements for Exblifep with Advanz Pharma in Europe and with Shanghai Haini Pharmaceutical in China.

The company is in “discussions with strategic partners” for launching Exblifep in the U.S., Buchanan said in a statement.

As for the complete response letter (CRL) the FDA sent to Venatorx and Melinta, the regulator did not flag any clinical safety or efficacy problems but did identify a manufacturing issue.

The companies' efforts with the combo are being funded by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.