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The purpose of this article is to review the available trials that led to the Food and Drug Administration (FDA) approval of berotralstat, an oral kallikrein inhibitor, for the prevention of hereditary angioedema (HAE) attacks. PubMed and ClincalTrials.gov were searched using key term to identify phase III clinical trials related to the FDA approval of berotralstat from April 2018 to May 2021. Trials selected were those that influenced the FDA approval of berotralstat or provided novel information regarding the safety and efficacy of t
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