FDA issues Complete Response for SPR 994 in complicated urinary tract infection.- Spero Therapeutics

The FDA had set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022.

In the CRL, the FDA communicated that it had completed its review of the NDA and determined that the NDA could not be approved in its present form. As previously disclosed, the CRL was anticipated based on feedback received at the late cycle meeting, in which the agency outlined potential deficiencies in the application. In the CRL, the FDA ultimately concluded that Spero’s Phase III 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.