Drug updated on 10/28/2024
Dosage Form | Capsule (oral; 110 mg, 150 mg) |
Drug Class | Plasma kallikrein inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- In a network meta-analysis comparing the effectiveness of lanadelumab and berotralstat for preventing hereditary angioedema (HAE) attacks, lanadelumab (300 mg every 2 or 4 weeks) was found to be statistically more effective than berotralstat (150 mg and 110 mg once daily) in reducing HAE attack rates and achieving a ≥90% reduction in monthly attacks.
- A systematic review involving 15 studies with 912 participants showed that berotralstat, C1-Inhibitor (INH), and lanadelumab were effective in reducing the number of HAE attacks and improving quality of life. However, lanadelumab and C1-INH were specifically noted for reducing the severity of breakthrough attacks, which was not reported for berotralstat.
- No increase in adverse events, including serious adverse events, was reported for berotralstat, avoralstat, C1-INH (all forms), and lanadelumab compared with placebo in the systematic review of 15 studies involving 912 participants.
- Mortality was not reported in any of the included studies, and specific data on serious adverse events were not available for danazol, preventing any conclusions regarding its safety.
- Studies primarily included populations with Type I and II hereditary angioedema (HAE), confirming the effectiveness of berotralstat, C1-INH, danazol, and lanadelumab in reducing HAE attacks. No data were available for Type III HAE, limiting conclusions for this subgroup.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Orladeyo (berotralstat) Prescribing Information. | 2023 | BioCryst Pharmaceuticals, Inc., Durham, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Network meta-analysis for indirect comparison of lanadelumab and berotralstat for the treatment of hereditary angioedema | 2023 | Journal of Comparative Effectiveness Research |
Interventions for the long-term prevention of hereditary angioedema attacks | 2022 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
An expert panel's review on patients with hereditary angioedema switching from attenuated androgens to oral prophylactic therapy. | 2024 | Allergy and Asthma Proceedings |
Reviewing clinical considerations and guideline recommendations of C1 inhibitor prophylaxis for hereditary angioedema. | 2022 | Clinical and Translational Allergy |