Berotralstat

(Orladeyo®)

Orladeyo®

Drug updated on 10/28/2024

Dosage FormCapsule (oral; 110 mg, 150 mg)
Drug ClassPlasma 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.

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Summary
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  • 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 TitleYearSource
Orladeyo (berotralstat) Prescribing Information.2023BioCryst Pharmaceuticals, Inc., Durham, NC

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines