Neurocrine Biosciences (NBIX) won approval in the U.S. Tuesday to market Ingrezza, a new drug to treat patients suffering from tardive dyskinesia, a movement disorder.
Ingrezza is the first drug developed and approved by the San Diego-based biotech company.
The U.S. Food and Drug Administration granted Ingrezza a relatively clean label that does not include a black box safety warning against suicidality or depression.
That's a potential marketing advantage for the company as it likely competes against Teva (TEVA) , which secured approval last week for its own movement disorder drug Austedo to treat patients with Huntington's chorea. Austedo, however, carries a black box suicide safety warning. Teva has an approval decision date for Austedo in tardive dyskinesia set for August.
Tardive dyskinesia affects approximately 500,000 people in the U.S. and is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and face. These symptoms are associated with chronic exposure to dopamine receptor blockers such as antipsychotic medications and can be severe, persistent and irreversible.
"The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of Ingrezza represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope," said Neurocrine CEO Kevin Gorman, in a statement.
The Ingressa commercial launch will start on May 1, Neurocrine said.
Analysts have pegged potential peak sales for the drug at $1 billion for the tardive dyskenesia indication. Neurocrine is also developing the drug to treat tourette's syndrome.
According to the FDA, the efficacy of Ingrezza was demonstrated in a clinical trial of 234 participants that compared Ingrezza to placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received placebo. Ingrezza may cause serious side effects including sleepiness and heart rhythm problems, says the FDA.
Neurocrine shares closed Tuesday at $41.48, ahead of the Ingrezza approval announcement.