Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application
The FDA had set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022.
- The FDA had set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022.
- In the CRL, the FDA ultimately concluded that Speros Phase 3 cUTI study of tebipenem HBr (ADAPT-PO) was insufficient to support approval and that additional clinical study would be required.
- Spero intends to promptly request a Type A meeting with the FDA, to gain further insights as to the pathway forward towards a potential regulatory approval for tebipenem HBr.
- Tebipenem HBr is an investigational drug in the United States being developed for the treatment of cUTI, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited treatment options; tebipenem HBr is not FDA-approved.