Summary

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• 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.