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Phase III Clinical Study to Evaluate the Efficacy and Safety of PCSK9 Inhibitors in the Prevention of Chinese Heterozygous Familial Hypercholesterolemia

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Trial Profile

Phase III Clinical Study to Evaluate the Efficacy and Safety of PCSK9 Inhibitors in the Prevention of Chinese Heterozygous Familial Hypercholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2023

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At a glance

  • Drugs Tafolecimab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms CREDIT-2

    • Most Recent Events

    • 17 Aug 2023 According to Innovent Biologics media release, based on results from three Phase 3 registrational clinical trials (CREDIT-1, CREDIT-2, and CREDIT-4); Chinas National Medical Products Administration (NMPA) has approved SINTBILO (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia
    • 13 Jun 2022 According to Innovent Biologics media release, China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection for the treatment of primary hypercholesterolemia including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia and mixed dyslipidemia. The NDA submission was based on the study results of three phase 3 registration clinical trials (CREDIT-1, CREDIT-2 and CREDIT-4).
    • 13 Jun 2022 According to Innovent Biologics media release, the study results have been presented at the ACC meeting 2022.

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