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Lanadelumab: First Global Approval.
Drugs 2018; 78(15):1633-1637D

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

30267321

Citation

Syed, Yahiya Y.. "Lanadelumab: First Global Approval." Drugs, vol. 78, no. 15, 2018, pp. 1633-1637.
Syed YY. Lanadelumab: First Global Approval. Drugs. 2018;78(15):1633-1637.
Syed, Y. Y. (2018). Lanadelumab: First Global Approval. Drugs, 78(15), pp. 1633-1637. doi:10.1007/s40265-018-0987-2.
Syed YY. Lanadelumab: First Global Approval. Drugs. 2018;78(15):1633-1637. PubMed PMID: 30267321.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lanadelumab: First Global Approval. A1 - Syed,Yahiya Y, PY - 2018/9/30/pubmed PY - 2019/7/19/medline PY - 2018/9/30/entrez SP - 1633 EP - 1637 JF - Drugs JO - Drugs VL - 78 IS - 15 N2 - 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. SN - 1179-1950 UR - https://www.unboundmedicine.com/medline/citation/30267321/Lanadelumab:_First_Global_Approval_ L2 - https://dx.doi.org/10.1007/s40265-018-0987-2 DB - PRIME DP - Unbound Medicine ER -