Posted by Michael Wonder on 20 Jun 2020
Ovid Therapeutics receives FDA rare paediatric disease designation for OV101 for the treatment of Angelman syndrome
19 June 2020 - Ovid Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to OV101 (gaboxadol) for the treatment of Angelman syndrome.
OV101 is believed to be the only delta (δ)-selective GABAA receptor agonist in development and is currently being evaluated in the Company’s pivotal Phase 3 NEPTUNE trial in Angelman syndrome, with topline results expected in the fourth quarter of 2020.
The FDA has previously granted Orphan Drug and Fast Track designations for OV101 for the treatment of Angelman syndrome.
