Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 150 mg/1 mL [150 mg/ml] in a single-dose prefilled syringe, 300 mg/2 mL [150 mg/mL] in a single-dose prefilled syringe, 300 mg/2 mL [150 mg/mL] in a single-dose vial) |
Drug Class | Plasma kallikrein inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) attacks in adult and pediatric patients 2 years and older.
Latest News
Summary
- Takhzyro (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Lanadelumab (300 mg every 2 or 4 weeks) demonstrated statistically significant effectiveness over berotralstat (150 mg or 110 mg once daily) in reducing hereditary angioedema (HAE) attack rates per 28 days and achieving a ≥90% reduction in monthly HAE attacks.
- All drugs except avoralstat were effective in reducing the number of HAE attacks compared to placebo, with lanadelumab and various forms of C1-INH notably effective in reducing the severity of breakthrough attacks. Quality of life improvements were observed for avoralstat, berotralstat, C1-INH (all forms), and lanadelumab compared to placebo.
- The findings apply to individuals with Type I and II HAE, with no data available for Type III HAE. The effectiveness of lanadelumab and C1-INH in reducing the severity of breakthrough attacks was highlighted, but data on other drugs for this outcome were lacking.
- In the systematic review, adverse events, including serious adverse events, occurred at rates comparable to placebo for all drugs studied (avoralstat, berotralstat, subcutaneous C1-INH, plasma-derived C1-INH, nanofiltered C1-INH, recombinant human C1-INH, danazol, and lanadelumab). Specific serious adverse events included hepatic dysfunction, hepatic toxicity, and deleterious changes in blood tests; however, data for danazol were insufficient for conclusive safety assessment.
- No deaths were reported in any of the studies included in the systematic review.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Takhzyro (Lanadelumab-flyo) Prescribing Information. | 2023 | Takeda Pharmaceuticals U.S.A. Inc., Lexington, MA |
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 |
Breakthroughs in hereditary angioedema management: a systematic review of approved drugs and those under research. | 2019 | Drugs in Context |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Reviewing clinical considerations and guideline recommendations of C1 inhibitor prophylaxis for hereditary angioedema. | 2022 | Clinical and Translational Allergy |
Consensus on diagnosis and management of Hereditary Angioedema in the Middle East: a Delphi initiative. | 2022 | The World Allergy Organization Journal |
Assessment and management of disease burden and quality of life in patients with hereditary angioedema: a consensus report. | 2021 | Allergy, Asthma & Clinical Immunology |
US HAEA medical advisory board 2020 guidelines for the management of hereditary angioedema. | 2020 | The Journal of Allergy and Clinical Immunology: in Practice |
The International/Canadian hereditary angioedema guideline. | 2019 | Allergy, Asthma & Clinical Immunology |