FDA Designates Zealand Product as Orphan Drug

The FDA granted an orphan-drug designation to Zealand’s glepaglutide medication for short-bowel syndrome.

Zealand, based in Denmark, said the drug completed phase II clinical trials, with phase III trials planned for 2018.

Short-bowel syndrome can occur after major intestinal surgery for Crohn’s disease, ischemia, radiation damage and other conditions. It can result in complete loss of intestinal function.