Local drugmaker Neurocrine Biosciences Inc. has been given a speedier path to drug approval by regulators, the company announced Tuesday.
The U.S. Food and Drug Administration has accepted Neurocrine’s New Drug Application for Ingrezza, a treatment for tardive dyskinesia, a condition that’s characterized by involuntary, repetitive body movements, including lip smacking, grimacing and pursing of the lips. There are no FDA-approved treatments for the condition.
The FDA also granted the drug “Priority Review.” The designation accelerates the FDA review timeline from 10 months to 6 months.
The speedier path to approval is granted when the FDA believes that the drug, if approved, would be a significant improvement in the safety or effectiveness of a serious condition.
This isn’t the first special designation Ingrezza has received. The drug previously landed Fast Track status and Breakthrough Designation status from the FDA.
"This is another significant milestone for Neurocrine and more importantly those patients who are suffering from tardive dyskinesia," said Kevin C. Gorman, president and CEO of Neurocrine, in a statement. "We will continue to work with the FDA in their review of the Ingrezza NDA to potentially bring this important treatment option to patients and physicians."