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Innovent Reports the NMPA Acceptance of NDA for Tafolecimab to Treat Primary Hypercholesterolemia and Mixed Dyslipidemia

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Innovent Reports the NMPA Acceptance of NDA for Tafolecimab to Treat Primary Hypercholesterolemia and Mixed Dyslipidemia

Innovent Reports the NMPA Acceptance of NDA for Tafolecimab to Treat Primary Hypercholesterolemia and Mixed Dyslipidemia

Shots:

  • 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, and 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 

Click here to­ read the full press release 

Neha

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.

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