VectivBio Gets Orphan Drug Designation for Apraglutide
June 24 2021 - 6:52AM
Dow Jones News
By Chris Wack
VectivBio Holding AG said the U.S. Food and Drug Administration
has granted orphan drug designation to apraglutide, a long-acting
GLP-2 analog being developed for rare gastrointestinal diseases,
for the prevention of acute graft-versus-host disease.
The biopharmaceutical company said it plans to initiate a Phase
2 trial evaluating apraglutide for the treatment of aGVHD in the
first quarter of 2022.
The FDA's Orphan Drug Designation program is designed to advance
the development of drugs and biologics intended to treat, prevent
or diagnose rare diseases affecting less than 200,000 people in the
U.S.
Orphan Drug Designation incentives and benefits may include
seven years of market exclusivity post-regulatory approval, tax
credits for qualified clinical trial expenses and a waiver of the
Prescription Drug User Fee Act filing fee.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 24, 2021 07:48 ET (11:48 GMT)
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