The US Food & Drug Administration (FDA) sent a response letter to Spero Therapeutics regarding its New Drug Application (NDA) for tebipenem pivoxil hydrobromide (tebipenem HBr) to treat complicated UTIs, saying the application lacks sufficient data.
The NDA was supported by data from the phase 3 ADAPT-PO trial which demonstrated that tebipenem HBr had noninferior efficacy and safety compared to intravenous ertapenem.1
The FDA’s Complete Response Letter (CRL) was expected, according to an earlier press release from Spero, as a result of the late cycle meeting during which the FDA outlined potential deficiencies. The CRL ultimately concluded that the phase 3 ADAPT-PO trial of tenipenem HBr was insufficient and requires additional clinical study.
“We are disappointed with the FDA’s decision, but we look forward to our continued dialogue, addressing the agency’s concerns and outlining a clear path forward for tebipenem HBr,” said Ankit Mahadevia, MD, chief executive officer of Spero Therapeutics. “With this development, we continue to believe that tebipenem HBr offers patients and their providers an important new treatment option, that if approved, has the potential to address the critical unmet need for a new oral antibiotic for patients.”