Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study

H Farkas, M Stobiecki, J Peter… - Clinical and …, 2021 - Wiley Online Library
Background Berotralstat (BCX7353) is an oral, once‐daily inhibitor of plasma kallikrein
recently approved for prevention of angioedema attacks in adults and adolescents with …

[HTML][HTML] Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: a randomized, double-blind, placebo-controlled phase 3 trial

B Zuraw, WR Lumry, DT Johnston… - Journal of Allergy and …, 2021 - Elsevier
Background Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein in
development for the prophylaxis of hereditary angioedema (HAE) attacks. Objective Our aim …

[HTML][HTML] Once-daily oral berotralstat for long-term prophylaxis of hereditary angioedema: the open-label extension of the APeX-2 randomized trial

S Kiani-Alikhan, R Gower, T Craig, HJ Wedner… - The Journal of Allergy …, 2024 - Elsevier
Background Berotralstat is a first-line, once-daily oral plasma kallikrein inhibitor approved for
prophylaxis of hereditary angioedema (HAE) attacks in patients 12 years or older. Objective …

[HTML][HTML] Randomized trial of the efficacy and safety of berotralstat (BCX7353) as an oral prophylactic therapy for hereditary angioedema: results of APeX-2 through 48 …

HJ Wedner, E Aygören-Pürsün, J Bernstein… - The Journal of Allergy …, 2021 - Elsevier
Background Berotralstat (BCX7353) is a recently approved, oral, once-daily kallikrein
inhibitor for hereditary angioedema (HAE) prophylaxis. In the APeX-2 trial, berotralstat …

[HTML][HTML] Berotralstat (BCX7353) is a novel oral prophylactic treatment for hereditary angioedema: review of phase II and III studies

ME Manning, JM Kashkin - Allergy and Asthma Proceedings, 2021 - ingentaconnect.com
Background: Hereditary angioedema (HAE) is a rare genetic disorder characterized by
unpredictable and potentially life-threatening episodes of swelling in various parts of the …

A review of berotralstat for the treatment of hereditary angioedema

H Farkas, Z Balla - Expert Review of Clinical Immunology, 2023 - Taylor & Francis
Introduction Hereditary angioedema due to C1-inhibitor deficiency (C1-INH-HAE) imposes a
significant disease burden on patients and their families. Unpredictable episodes of …

Oral berotralstat for the prophylaxis of hereditary angioedema attacks in patients in Japan: a phase 3 randomized trial

I Ohsawa, D Honda, Y Suzuki, T Fukuda, K Kohga… - Allergy, 2021 - Wiley Online Library
Background With no approved treatments in Japan for the prevention of hereditary
angioedema (HAE) attacks, there is a significant unmet need for long‐term prophylactic …

Evaluation of patient‐reported outcome measures for on‐demand treatment of hereditary angioedema attacks and design of KONFIDENT, a phase 3 trial of …

DM Cohn, E Aygören‐Pürsün… - Clinical and …, 2023 - Wiley Online Library
Background Hereditary angioedema (HAE) with C1‐inhibitor deficiency (HAE‐C1‐INH) is
characterized by recurrent, debilitating episodes of swelling. Sebetralstat, an investigational …

An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled …

E Aygören-Pürsün, A Zanichelli, DM Cohn, M Cancian… - The Lancet, 2023 - thelancet.com
Background Guidelines recommend effective on-demand therapy for all individuals with
hereditary angioedema. We aimed to assess the novel oral plasma kallikrein inhibitor …

[HTML][HTML] A retrospective analysis of long-term prophylaxis with berotralstat in patients with hereditary angioedema and acquired C1-inhibitor deficiency—real-world …

F Johnson, A Stenzl, B Hofauer, H Heppt… - Clinical Reviews in …, 2023 - Springer
Hereditary angioedema (HAE) and acquired C1-inhibitor deficiency (AAE-C1-INH) are
orphan diseases. Berotralstat is a recently licensed long-term prophylaxis (LTP) and the first …