Innovent’s Sintbilo (tafolecimab) Receives the NMPA’s Approval for Adult Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia
Shots:
- The approval was based on the 2 P-III registrational trials (CREDIT-1/2/4) evaluating tafolecimab (lgG2 fully human mAb) in adult patients with primary hypercholesterolemia & mixed dyslipidemia
- In (CREDIT-1) trial for (450mg, q4w) & (600mg, q6w)/(CREDIT-2) trial for (150mg, q2w) & (450mg, q4w/(CREDIT-4) trial for (450mg, q4w), treatment difference of mean change in LDL-C level from baseline was –65.04% & –57.31% at 48wk./ 57.37% & –61.90% at 12wk./–63.02%; ≥50% reduction in LDL-C from baseline was 87.8% & 71.8% vs 1.0% & 2.0%/59.6% & 75.0% vs 0/90.5% vs 2.0%, respectively
- All approved dosing regimens are effective in reducing LDL-C, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B (ApoB), and (Lp(a)levels
Ref: PRNewswire | Image: Innovent
Related News:- Innovent Presents P-III (CREDIT-1) Trial Results of Tafolecimab for Non-Familial Hypercholesterolemia at AHA 2022
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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.
