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Spero Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022 CAMBRIDGE, Mass., Jan. 03, 2022 (GLOBE NEWSWIRE) -- Spero
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022\nCAMBRIDGE, Mass., Jan. 03, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment in adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible microorganisms. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these cUTI indications. The Agency is planning to hold an Advisory Committee meeting to discuss this application and has also set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022. “The FDA acceptance of this NDA is a major step forward in our mission to provide patients the first and only oral carbapenem antibiotic to treat cUTI. If approved, tebipenem HBr may provide patients an oral treatment option, allowing them to potentially either recover at home from their infections or leave the hospital sooner,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “This is an important accomplishment and an exciting moment for all of us at Spero, as we execute our plan on becoming a commercial organization. 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.” The NDA submission includes previously communicated positive data from the Phase 3 ADAPT-PO trial. These data showed that ADAPT-PO met its primary endpoint by demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis (AP). David Melnick, M.D., Chief Medical Officer of Spero, added, “ADAPT-PO was rigorously designed both to support this NDA and to provide physicians with the confidence needed to prescribe oral tebipenem HBr to appropriate patients in place of IV therapy, if approved. We believe the positive results from the trial have allowed us to accomplish this first goal and indicate that use of tebipenem HBr may ultimately...