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HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)

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Trial Profile

HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2023

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At a glance

  • Drugs Lanadelumab (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions
  • Acronyms HELP; HELP Study Extension TM; HELP study OLE
  • Sponsors Dyax; Shire; Takeda

    • Most Recent Events

    • 05 Apr 2023 Results measuring the impact of long-term lanadelumab treatment on patient-reported outcomes, published in the Annals of Allergy, Asthma and Immunology
    • 13 Feb 2023 According to a Takeda Pharma media release,company announced US FDA's approval of expanded use of TAKHZYRO for prophylaxis to prevent attacks of HAE in pediatric patients 2 to <12 years of age, based on an extrapolation of efficacy data and pharmacokinetics analyses from this study.
    • 14 Nov 2022 Results assessing the comparative effectiveness of lanadelumab and berotralstat for prevention of HAE attacks at 48 weeks using MAIC from HELP OLE and APeX-2 part 2 studies, presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology.
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