www.fdanews.com/articles/179756-biohaven-achieves-orphan-drug-designation-for-als-drug-candidate
Biohaven Achieves Orphan Drug Designation for ALS Drug Candidate
December 19, 2016
The FDA has granted an orphan drug designation to Biohaven’s drug candidate BHV-0223, a developing treatment for amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.
BHV-0223 is administered under the tongue as a dissolving tablet.
Biohaven plans to conduct a bioequivalence study for the candidate in 2017.