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Drug updated on 5/17/2024
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.
Summary
- Lanadelumab-flyo (Takhzyro) is indicated for the prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 2 years and older. It has been found to be more effective than berotralstat in preventing HAE attacks, demonstrating statistically significantly higher effectiveness.
- The analysis is based on three systematic reviews/meta-analyses that focused on the safety, effectiveness, population types, and subgroup considerations of Takhzyro compared to other drugs used for the prevention of HAE attacks.
- While no direct comparison regarding safety profiles was made in these studies, it is highlighted that treatments for HAE, including Takhzyro, minimize the risk of death but are not curative. Understanding efficacy, route, and timing of administration is crucial, though specific comparative data were not provided.
- The studies primarily involved individuals with Type I and II HAE; however, there was no information provided about Type III or direct subgroup analyses. This indicates a need for further research into diverse populations.
- In addition to reducing the frequency of attacks, Takhzyro also increases the quality of life compared with placebo while decreasing the severity of breakthroughs when they occur, indicating dual benefits that enhance the overall well-being of patients.
- Takhzyro shows a high level of effectiveness in preventing HAE attacks, notably higher than berotralstat in indirect comparison. The safety profile appears in line with other therapeutic options, with no increased risk of serious adverse events reported. However, this conclusion is drawn from indirect comparisons and individual drug assessments rather than head-to-head clinical trials, suggesting a cautious interpretation of superiority claims until robust data become available.
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 |