Ovid Therapeutics Receives Orphan Drug Designation from the European Commission for OV101

Ovid Therapeutics (NASDAQ:OVID) has announced that the European Commission granted the company orphan designation for OV101 to treat Angelman syndrome.

As quoted in the press release:

“We are proud to be granted Orphan Drug Designation by the European Commission. This is another important step and further validates the potential of OV101 to be a meaningful treatment option for those living with Angelman syndrome around the world,” said Amit Rakhit, MD, MBA, Chief Medical Officer and Head of Research & Development at Ovid. “Today, there are no approved medicines specifically for Angelman syndrome. Ovid previously received Orphan Drug and Fast Track designation for OV101 from the U.S. Food and Drug Administration (FDA). We recently announced we have initiated the pivotal Phase 3 NEPTUNE trial in Angelman syndrome and have a clear route to registration, if positive.”

Dr. Rakhit continued, “It is believed that in the U.S. there are approximately 24,000 individuals with Angelman syndrome and a similar number in the European Union. OV101 is the only medicine currently in clinical development for Angelman syndrome. It’s our intent for OV101 to be the first medicine to be approved for this important and underserved community.”

Click here to read the full press release.