FDA grants orphan drug designation to OV101 for Angelman Syndrome
Release Date: 12-Oct-2016
Ovid therapeutics, a private pharmaceutical company from New York, developed OV101 for the treatment of angelman syndrome. Food and Drug Association, U.S, has approves OV101 as orphan drug designation.
OV101 is the first potential therapy to target the disruption of tonic inhibition, a key mechanism that allows the brain to fine-tune neurological signaling and accurately decipher excitatory from inhibitory signals, seen in this disorder.
Angelman Syndrome is a rare genetic disorder which causes developmental and neurologic disabilities such as difficulty in speaking, balancing and walking, as well as other symptoms such as anxiety, sleep disturbances and seizures.
FDA grants orphan drug status for rare and life threatening diseases that affect less than 200,000 people per year in the U.S. Also, FDA provide several beneficiaries to drug developers including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
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