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Review
. 2021 Feb;81(3):405-409.
doi: 10.1007/s40265-021-01475-4.

Berotralstat: First Approval

Arnold Lee  1
Affiliations
Review

Berotralstat: First Approval

Arnold Lee. Drugs. 2021 Feb.

Abstract

Berotralstat (ORLADEYO™) is an orally administered kallikrein inhibitor, which has been developed by BioCryst Pharmaceuticals for hereditary angioedema (HAE). The inhibition of kallikrein by berotralstat decreases the production of bradykinin, which prevents the localised tissue oedema that occurs during attacks of HAE. Berotralstat has been approved in the USA, and subsequently in Japan, for prophylaxis to prevent attacks of HAE in adults and paediatric patients aged 12 years or older. This article summarises the milestones in the development of berotralstat leading to this first approval for prophylaxis to prevent attacks of HAE.

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References

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    1. BioCryst Pharmaceuticals. BioCryst announces FDA approval of ORLADEYO™ (berotralstat), first oral, once-daily therapy to prevent attacks in hereditary angioedema patients [media release]. 3 Dec 2020. https://ir.biocryst.com/ .
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