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A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects With Hereditary Angioedema

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Trial Profile

A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects With Hereditary Angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2023

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At a glance

  • Drugs Lanadelumab (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire; Takeda

    • Most Recent Events

    • 01 Nov 2023 Results of safety and efficacy of lanadelumab , published in the Journal of Dermatology
    • 28 Mar 2022 According to a Takeda Pharma media release, the company has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TAKHZYRO TAKHZYRO (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan, based on data from HELP, HELP Study Open-label Extension (OLE) and NCT04180163.
    • 23 Sep 2021 Status changed from recruiting to completed.

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