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Spero Therapeutics (SPRO) Receives CRL from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application

June 27, 2022 4:06 PM EDT

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Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis. 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 in Spero’s May 3, 2022 press release, 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 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.

“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, M.D., 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 with cUTI.”

Dr. Mahadevia continued, “Our commitment to the development of effective new agents to address unmet medical needs remains strong, as we seek to identify the optimal path forward for tebipenem’s regulatory approval, commercialization, and value creation, potentially through external partnerships. Tebipenem HBr remains an important part of the Spero pipeline and a complement to our SPR720 and SPR206 programs, which we continue to advance towards key clinical and regulatory milestones.”

Tebipenem HBr Research SupportSelect tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.



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