Spero Therapeutics Announces FDA Acceptance of NDA for Urinary Tract Infection Drug

Spero Therapeutics’ new drug application (NDA) for its investigational urinary tract infection therapy, tibpenem HBr, has been accepted for review by the FDA and given a Priority Review designation that will ensure a speedier agency assessment.

The company’s NDA was supported by positive phase 3 data showing tibpenem HBr was noninferior to intravenous ertapenem for treating patients with complicated urinary tract infections as well as patients with acute pyelonephritis, a severe type of kidney inflammation.

The experimental pill has also received FDA Qualified Infectious Disease Product and Fast-Track designations. The agency has set a Prescription Drug User Fee Act-mandated target decision date of June 27, 2022.

“We are committed to working closely with the FDA throughout the NDA review process and look forward to tebipenem HBr’s anticipated launch in the second half of 2022,” said Spero’s CEO Ankit Mahadevia.