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Lanadelumab: First Global Approval

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Abstract

Shire is developing lanadelumab (Takhzyro™) for the prevention of hereditary angioedema (HAE) attacks. Lanadelumab is a fully human monoclonal antibody that inhibits plasma kallikrein. Mutations in the SERPING1 gene lead to C1 inhibitor deficiency or dysfunction, resulting in uncontrolled plasma kallikrein activity, which in turn produces excessive bradykinin, a vasodilator thought to cause angioedema symptoms. Subcutaneous administration of lanadelumab significantly reduced HAE attacks versus placebo in patients aged ≥ 12 years with type I or II HAE in a phase III trial. Based on these results, lanadelumab is recently approved in the USA for the prevention of HAE attacks in patients aged ≥ 12 years. It is also preregistered in the EU, Canada, Australia and Switzerland. This article summarizes the milestones in the development of lanadelumab leading to this first approval.

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Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Yahiya Y. Syed

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  1. Yahiya Y. Syed
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Correspondence to Yahiya Y. Syed.

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The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yahiya Y. Syed is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Syed, Y.Y. Lanadelumab: First Global Approval. Drugs 78, 1633–1637 (2018). https://doi.org/10.1007/s40265-018-0987-2

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