Spero Therapeutics Submits NDA for Treatment of Urinary Tract Infections
October 28 2021 - 8:46AM
Dow Jones News
By Chris Wack
Spero Therapeutics Inc. 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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 28, 2021 08:31 ET (12:31 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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