VectivBio Gets Orphan Drug Designation for Apraglutide

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)

VectivBio (NASDAQ:VECT)
Historical Stock Chart
From Mar 2024 to Apr 2024