Spero Therapeutics Gets FDA Priority Review of Tebipenem HBr

By Colin Kellaher

Spero Therapeutics Inc. on Monday said the U.S. Food and Drug Administration granted priority review to its application seeking approval of tebipenem HBr oral tablets for adults with complicated urinary tract infections, including acute pyelonephritis.

The Cambridge, Mass., clinical-stage biopharmaceutical company said the FDA is planning to hold an advisory committee meeting to discuss the application, adding that the agency set a target action date of June 27.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Spero said it plans to work closely with the FDA throughout the review process, adding that it hopes to launch tebipenem HBr, its lead product candidate, in the second half of the year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

01-03-22 0839ET