By Chris Wack
Soleno Therapeutics said that the Food and Drug Administration has granted Breakthrough Therapy Designation for diazoxide choline extended-release tablets for the treatment people 4 years and older with genetically confirmed Prader-Willi syndrome who have hyperphagia.
The biopharmaceutical company said the designation shows that diazoxide choline may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
Soleno expects to submit a New Drug Application for diazoxide choline in mid-2024.
The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of drugs in the U.S. that are intended to treat a serious condition.
Diazoxide choline has Orphan Drug Designation for Prader-Willi syndrome
in the U.S. and E.U., as well as Fast Track Designation in the U.S.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
04-29-24 0851ET