Generic name: valbenazine
Disease: tardive dyskinesia
2022 sales estimate: $1.3 billion
It won’t be long before San Diego-based Neurocrine has an FDA decision on Ingrezza, its med for the involuntary movement condition tardive dyskinesia. After awarding the candidate fast track status and a breakthrough therapy designation, U.S. regulators accepted the company’s application under their priority review system, and they’re due to hand down a verdict by April 11.
Assuming Ingrezza gets a green light, it’ll become the first FDA-approved med to treat the malady, which causes repetitive movements including lip-smacking, grimacing and blinking. But Neurocrine isn’t stopping there.
It’s also in phase 2 with the compound as a treatment for the verbal and movement tic disorder Tourette syndrome, though on that front, it recently hit a snag. In mid-January, the company announced it had missed its primary endpoint—change-from-baseline improvement on the Yale Global Tic Severity Scale—in an adult study.
On the bright side, though, the treatment did significantly improve overall symptoms, Neurocrine said, and the study didn’t turn up any new safety red flags. Additionally, “insights gleaned from the study should help inform the development of an appropriate phase 3 protocol,” Barclays analyst Geoff Meacham wrote in a note to clients, noting that “we view the results as generally positive.”
Next up, Neurocrine is expecting pediatric Tourette data in late March or early April, and that’ll be key for the med’s Tourette development. “The pediatric work is the main focus for Neurocrine,” Meacham pointed out.