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