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# Allecra NDA Approval for Antibiotic
- URL: https://www.fdaweb.com/allecra-nda-approval-for-antibiotic/
- Published: 2024-03-01T12:00:00.000Z
- Updated: 2026-09-14T14:24:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156465

FDA has approved an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. For obtaining approval, the agency granted to company a five-year marketing exclusivity extension under the Generating Antibiotic Incentives Now Act.

The approval was based submission was based on [results from Allecra’s Phase 3 ALLIUM trial](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.biospace.com%2Farticle%2Freleases%2Fallecra-therapeutics-publishes-final-phase-3-allium-data-in-jama-cefepime-enmetazobactam-met-criteria-for-superiority%2F%3Fkeywords%3DAllecra&esheet=53901831&newsitemid=20240227132611&lan=en-US&anchor=results+from+Allecra%26%238217%3Bs+Phase+3+ALLIUM+trial&index=2&md5=1f93547c71e0f8633e26cb171f488943&ref=fdaweb.com), which “met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary composite outcome of clinical cure and microbiological eradication in patients with cUTIs,” according to the company.