Vanda Pharmaceuticals Gains Orphan Drug Status for Investigational Cholera Drug
Vanda Pharmaceuticals’ VPO-227 has received FDA’s Orphan Drug designation for the treatment of patients with cholera.
VPO-227 blocks the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, which plays a role in cholera-induced intestinal fluid loss.
The company plans on submitting an Investigational New Drug application for the drug candidate in 2023.
The Orphan Drug designation exempts drug sponsors from FDA user fees and potentially offers them seven years of market exclusivity after a drug’s approval.