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Related Experiment Video

Updated: Feb 4, 2026

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Lanadelumab: First Global Approval.

Yahiya Y Syed1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

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|September 30, 2018
PubMed
Summary

Lanadelumab (Takhzyro™) effectively prevents hereditary angioedema (HAE) attacks by inhibiting plasma kallikrein. This new treatment significantly reduced HAE attacks in a phase III trial, leading to its recent approval.

Area of Science:

  • Immunology
  • Genetics
  • Pharmacology

Background:

  • Hereditary angioedema (HAE) is caused by C1 inhibitor deficiency or dysfunction.
  • This leads to uncontrolled plasma kallikrein activity and excessive bradykinin production.
  • Bradykinin is a vasodilator implicated in angioedema symptoms.

Purpose of the Study:

  • To summarize the development of lanadelumab (Takhzyro™).
  • To highlight its efficacy in preventing hereditary angioedema (HAE) attacks.
  • To document its recent regulatory approvals.

Main Methods:

  • Lanadelumab, a fully human monoclonal antibody, targets plasma kallikrein.
  • A phase III trial evaluated subcutaneous lanadelumab versus placebo in HAE patients (≥12 years).
  • The study assessed the reduction in HAE attack frequency.

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Main Results:

  • Subcutaneous lanadelumab significantly reduced HAE attacks compared to placebo.
  • Efficacy was demonstrated in patients aged 12 years and older with type I or II HAE.
  • The drug's safety and tolerability profile supported its approval.

Conclusions:

  • Lanadelumab is a novel therapeutic for HAE attack prevention.
  • Its approval marks a significant advancement in HAE management.
  • Further research may explore long-term outcomes and broader patient populations.