Drug updated on 4/17/2024
| Dosage Form | Injection (subcutaneous: 300 mg/2 mL (150 mg/mL)) |
| Drug Class | Plasma kallikrein inhibitors (monoclonal antibodies) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Summary
- Lanadelumab (Takhzyro-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
- A total of three systematic reviews/meta-analyses were reviewed, providing insights into the effectiveness and management strategies involving lanadelumab.
- According to a network meta-analysis, lanadelumab administered every 2 or 4 weeks was associated with significantly higher effectiveness compared to berotralstat for preventing HAE attacks; this included both attack rate per month and ≥90% reduction in monthly HAE attacks.
- Another review highlighted that during an acute HAE attack, treatment options include C1-INH replacement therapy as well as other drugs like icatibant, ecallantide or fresh frozen plasma; however long-term prophylaxis should be considered for those who suffer from frequent severe attacks - one such option being monoclonal antibodies targeting plasma kallikrein which includes lanadelumab.
- The same study also emphasized the importance of prompt recognition by physicians due to potential life-threatening risks posed by distal involvement of upper airway especially larynx during acute presentation of HAE – highlighting the critical role played by treatments like lanadelumab in managing these conditions effectively.
- In another review focusing on approved drugs for treating C1-inhibitor defect related HAE including lanadelumab, it was noted that while current therapies can minimize risk of death they are not effective at completely curing disease – pointing towards unmet needs regarding efficacy along with route & timing administration considerations even with existing treatments like Takhzyro-flyo (lanadelumb).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Takhzyro (Lanadelumab-flyo) Prescribing Information. | 2022 | 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 | Cochrane Database of Systematic Reviews |
| Clinical manifestations of hereditary angioedema and a systematic review of treatment options. | 2021 | Laryngoscope Investigative Otolaryngology |
| Clinical review report: lanadelumab (Takhzyro) | 2020 | CADTH |
| Breakthroughs in hereditary angioedema management: a systematic review of approved drugs and those under research. | 2019 | Drugs in Context |
| Prophylaxis for hereditary angioedema with lanadelumab and C1 inhibitors: effectiveness and value . | 2018 | ICER |
| Assessment report: Takhzyro. | 2018 | EMA |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 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 |