The NDA was based on 3 P-III registration (CREDIT-1/2/4) trials evaluating tafolecimab (anti-PCSK-9 Ab) vs PBO in patients with primary HCL & mixed dyslipidemia
The results showed a 57% – 65% reduction in low-density LDL-C levels & maintained long-term therapeutic efficacy, reduction in TC, non-HDL-C, ApoB, & Lp (a)) levels. Tafolecimab achieved long-interval administration, overall favorable safety profiles & is expected to be an effective treatment for primary HCL & mixed dyslipidemia
The therapy also exhibited more prominent advantages in reducing LP over other similar anti-PSCK-9 agents which may lead to improved compliance & additional CV risk control benefits. The product is expected to be available shortly
Ref: PR Newswire | Image: Innovent
