Drug updated on 9/4/2024
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
- Orladeyo (berotralstat) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Lanadelumab (300 mg every 2 or 4 weeks) demonstrated significantly greater effectiveness than Berotralstat (150 mg or 110 mg once daily) in reducing HAE attack rates per 28 days and achieving ≥90% reduction in monthly HAE attacks.
- A systematic review indicated that Berotralstat, along with C1-INH (various forms) and lanadelumab, effectively reduced the number of HAE attacks and improved quality of life compared to placebo, but Avoralstat did not reduce HAE attacks.
- No head-to-head trials comparing these drugs in different HAE types (Type I, II, or III) were identified, limiting conclusions on specific population types or subgroups; no data were available for Type III HAE.
- Adverse events and serious adverse events for Berotralstat, as well as for other drugs like Avoralstat, C1-INH (all forms), and lanadelumab, did not occur at rates higher than placebo, and no deaths were reported in any of the included studies.
- Specific safety outcomes were not provided in the Network Meta-Analysis, and there were no significant safety concerns or adverse effects highlighted for any specific population types or subgroups.
- There is no population types or subgroups information available in the reviewed studies.
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 |
Management of pediatric hereditary angioedema types 1 and 2: a search for international consensus. | 2022 | Allergy and Asthma Proceedings |