The New Drug Application (NDA) for berotralstat (BCX7353; BioCryst) for the prevention of hereditary angioedema (HAE) attacks has been submitted to the Food and Drug Administration (FDA).

Berotralstat is an oral plasma kallikrein inhibitor that is administered once daily. The NDA includes data from the phase 3 APeX-2 trial that evaluated the safety and efficacy of berotralstat in preventing acute angioedema attacks in patients with Type I and Type II HAE. Results showed that treatment with berotralstat led to a significant reduction in the rate of HAE attacks compared with placebo.

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“Our commercial team is hard at work preparing to commercialize berotralstat in 2020,” said John Stonehouse, CEO of BioCryst. The Company is currently conducting an open-label study (APeX-S) to evaluate the long term safety and effectiveness of berotralstat in patients with Type I and Type II HAE. 

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