Drug updated on 5/17/2024
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
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Summary
- Berotralstat (Orladeyo) is indicated for the prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
- One study was relevant as it compared the effectiveness of Orladeyo with another drug, lanadelumab.
- The network meta-analysis described indicates that lanadelumab, administered at a dosage of 300 mg every two weeks or every four weeks, is statistically significantly more effective than Orladeyo taken at doses of 150 mg once daily or 110 mg once daily.
- Differences exist between dosing regimens; Orladeyo requires daily intake while lanadelumab can be administered bi-weekly or monthly, which may influence patient preference or adherence.
- While no detailed information on population types and subgroup considerations are provided by the study, they imply that data from Phase III trials were used for analysis. Further research would be needed to understand how its effectiveness might vary across different patient subgroups compared to lanadelumab.
- Comparative safety information between Orladeyo and Lanadelumab was not provided by these documents, which could limit a comprehensive understanding of their respective benefits and risks, especially over long-term use.
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 |