Neurocrine Biosciences’ Ingrezza (valbenazine) Capsules Receives the US FDA’s Approval for the Treatment of Chorea Associated with Huntington's Disease
Shots:
- The approval was based on the 2 studies incl. the P-III study (KINECT-HD) & (KINECT-HD2) OLE trial evaluating Ingrezza vs PBO in 128 & 150 patients aged 18 to 75yrs. The (KINECT-HD) trial met its 1EPs of LSM change in chorea severity using the TMC score of UHDRS from the screening period baseline to the maintenance period (avg. of 10 & 12wks.) & showed an improvement in TMC score
- 4.6 vs 1.4-point improvement in chorea severity score from the start to the end of the 12wk. study. 40% reduction in chorea severity from baseline to maintenance & half of the patients saw a ≥40% reduction in HD chorea severity by 12wk.
- 43% & 53% were classified as "much improved" or "very much improved" on CGI-C & PGI-C vs 13% & 26% on PBO at 12wk. The company launched an INBRACE support program that provides access to patients to use Ingrezza & offers a patient assistance program to eligible patients
Ref: PRNewswire | Image: Neurocrine
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
