Publication: Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study
Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study
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Farkas, H., Stobiecki, M., Peter, J., Kinaciyan, T., Maurer, M., Aygören‐Pürsün, E., Kiani‐Alikhan, S., Wu, A., Reshef, A., Bygum, A., Fain, O., Hagin, D., Huissoon, A., Jeseňák, M., Lindsay, K., Panovska, V. G., Steiner, U. C., Zubrinich, C., Best, J. M., … Sheridan, W. P. (2021). Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study. Clinical and Translational Allergy, 11, online. https://doi.org/10.1002/clt2.12035
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Background: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). The objective of this report is to summarize results from an interim analysis of an ongoing long-term safety study of berotralstat in patients with HAE.
Methods: APeX-S is an ongoing, phase 2, open-label study conducted in 22 countries (ClinicalTrials.gov, NCT03472040). Eligible patients with a clinical diagnosis of HAE due to C1 inh
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Farkas, H., Stobiecki, M., Peter, J., Kinaciyan, T., Maurer, M., Aygören‐Pürsün, E., Kiani‐Alikhan, S., Wu, A., Reshef, A., Bygum, A., Fain, O., Hagin, D., Huissoon, A., Jeseňák, M., Lindsay, K., Panovska, V. G., Steiner, U. C., Zubrinich, C., Best, J. M., … Sheridan, W. P. (2021). Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study. Clinical and Translational Allergy, 11, online. https://doi.org/10.1002/clt2.12035