Regulators with the U.S. Food and Drug Administration have handed Neurocrine Biosciences a special classification for one of its drug programs, granting the company a number of perks.
The status was granted for a drug called Ingrezza, which is already on the market to treat patients with tardive dyskinesia (TD). The condition is a nervous system disorder that causes uncontrollable stiff, jerky movements in the face and body (often caused by long-term use of psychiatric drugs). Before Ingrezza, there were no treatments for TD patients.
Now, Neurocrine hopes to expand the uses for Ingrezza to include treating children with Tourette Syndrome, which is characterized by motor and vocal tics. The drug is already being tested in humans for this condition.
The FDA just gave the drug Orphan Drug Designation for Tourettes in children, which will lighten the burden of development for Neurocrine. Perks of Orphan Drug status include reduced regulatory fees, guidance from the FDA, and extended market exclusivity if the drug is approved.