Shares in Neurocrine Biosciences Inc (NASDAQ:NBIX) shot up over 24% to $51.50 on US FDA approval news.
The FDA has approved INGREZZA (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD).
TD is a side effect of antipsychotic medications characterized by uncontrolled movements of the face and body.
INGREZZA is the first and only FDA-approved product indicated for the treatment of adults with TD, the biotech said.
The drug will now be in the distribution channel next week and will be available through a select pharmacy network. Promotion to healthcare professionals will begin in May this year.
"Until now, one of the few options for physicians, when managing TD, was to stop, change or lower the dose of antipsychotic medication, potentially jeopardizing patients' psychiatric stability," said Dr Christoph U. Correll, of the Hofstra Northwell School of Medicine.
"In clinical trials, INGREZZA significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care."
Kevin C. Gorman, Neurocrine Biosciences' chief executive, said: "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."