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SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age

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Trial Profile

SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2023

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At a glance

  • Drugs Lanadelumab (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms SPRING
  • Sponsors Shire

Most Recent Events

  • 17 Nov 2023 According to a Takeda Pharma media release, based on results from this trial, the European Commission has approved TAKHZYRO (lanadelumab) for the routine prevention of recurrent attacks of Hereditary Angioedema (HAE) in patients aged 2 years and older.
  • 22 Sep 2023 According to a Takeda Pharma media release, announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lanadelumab (trade name TAKHZYRO) for the routine prevention of Hereditary Angioedema (HAE) in patients aged 2 years and older based on data from Phase 3 Study SHP643-301, also known as the SPRING study.
  • 27 Feb 2023 Results of post-hoc exploratory analysis assessing health-related quality of life (HRQoL) in pediatric patients with HAE aged 2 to <12 years at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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