Spero's New Drug Application For Tebipenem HBr Tablets Granted Priority Review

(RTTNews) - Spero Therapeutics, Inc. (SPRO), said on Monday that the U.S. Food and Drug Administration or FDA has granted priority review designation and confirmed a substantive review of the New Drug Application or NDA, for tebipenem HBr oral tablets.

The tablets are to treat complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible microorganisms, in adult patients.

FDA is also 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, the drug maker said in a statement.

Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these cUTI indications.

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)," Spero added.