Lanadelumab-flyo

(Takhzyro®)

Lanadelumab-flyo

Drug updated on 12/11/2024

Dosage FormInjection (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 ClassPlasma 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.

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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]
  • 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-intravenous and subcutaneous forms (INH) 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 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 TitleYearSource
Takhzyro (lanadelumab-flyo) Prescribing Information.2023Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines