Neurocrine Biosciences’ Valbenazine Receives the US FDA’s Orphan Drug Designation for the Treatment of Chorea Associated with Huntington Disease

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The US FDA has granted ODD to valbenazine for the treatment of HD. The company reported the results from the P-III (KINECT-HD) study that evaluates valbenazine (qd) vs PBO in 128 adults aged 18 to 75yrs. with chorea associated with HD
The study met the 1EPs i.e., reduction in chorea movements as measured by a change in UHDRS TMC score from baseline to avg. score @10 & 12wks. & a mean reduction in TMC score while 2EPs of CGI-C response status & PGI-C response were also in favor of valbenazine treatment
Additionally, patient enrollment is ongoing in the (KINECT-HD2) study to evaluate the safety & tolerability of valbenazine for chorea in HD. The company is planning to submit sNDA to the US FDA in 2022

Ref: PR Newswire | Image: Neurocrine

Category: News