Drug updated on 10/29/2024
| 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 or vial) |
| Drug Class | Plasma kallikrein inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Lanadelumab 300 mg administered every 2 or 4 weeks was statistically significantly more effective in reducing the Hereditary Angioedema (HAE) attack rate compared to berotralstat (150 mg once daily and 110 mg once daily), achieving a ≥90% reduction in monthly HAE attacks at a higher rate than berotralstat.
- Lanadelumab effectively reduced the number and severity of HAE attacks, improved quality of life, and decreased disability in individuals with Type I and Type II HAE, while all drugs except avoralstat were shown to lower the incidence of HAE attacks compared to placebo.
- Both lanadelumab and C1-INH (intravenous and subcutaneous forms) were comparable in reducing the severity of breakthrough attacks and in enhancing quality of life and disability compared to placebo.
- Lanadelumab did not increase the risk of adverse events, including serious adverse events, compared with placebo, and no serious adverse events were reported at a higher rate than placebo; additionally, no deaths were reported in any of the included studies.
- Berotralstat, C1-INH (all forms), and avoralstat similarly did not show an increased rate of adverse events or serious adverse events compared with placebo, indicating a favorable safety profile for these treatments.
- The studies included participants with Type I and Type II Hereditary Angioedema (HAE), demonstrating that lanadelumab effectively reduced the number of HAE attacks, severity of breakthrough attacks, and improved quality of life and disability; however, no studies addressed Type III HAE, limiting conclusions for this subgroup.
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 |
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 |