Spero Therapeutics Inc. shares were up 7% at $17.42 after the company said it submitted a new drug application to the U.S. Food and Drug Administration seeking approval for tebipenem HBr tablets for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible microorganisms.
The biopharmaceutical company said that if approved, tebipenem HBr would be the only oral carbapenem antibiotic available for use in cUTI.
Spero said it will work with the FDA during the NDA review process as it prepares for tebipenem HBr's anticipated launch in the second half of 2022.
The NDA submission includes previously communicated positive data from its Phase 3 trial. The data showed that the trial met its primary endpoint by demonstrating that oral tebipenem HBr was statistically non-inferior to IV ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis.
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