Burosumab-twza

(Crysvita®)

Burosumab-twza

Drug updated on 9/4/2024

Dosage FormInjectable (subcutaneous; 10 mg/mL, 20 mg/mL, 30 mg/mL)
Drug ClassMonoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
  • Indicated for the treatment of FGF23-related hypophosphatemia in tumor induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.

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Summary
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  • Crysvita (burosumab-twza) is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older, and for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Burosumab significantly increased serum phosphorus levels in patients with X-linked hypophosphatemia (XLH), with an increase of 0.52 mg/dL (95% CI 0.24-0.80 mg/dL) in randomized controlled trials and 0.78 mg/dL (95% CI 0.61-0.96 mg/dL) in the overall meta-analysis.
  • In XLH patients, Burosumab significantly increased TmP/GFR by 0.86 mg/dL (95% CI 0.60-1.12 mg/dL) and 1,25-dihydroxyvitamin D levels by 13.23 pg/mL (95% CI 4.82-21.64 pg/mL), demonstrating effectiveness in improving phosphate metabolism.
  • Burosumab is highlighted as a promising nonsurgical therapy for patients with tumor-induced osteomalacia (TIO), especially in cases of persistent, recurrent, or inoperable TIO, with evidence of potential effectiveness in a small cohort of patients.
  • In RCTs, the safety profile of burosumab in patients with X-linked hypophosphatemia (XLH) was not significantly different from the control group.
  • In single-arm trials for XLH, there was a high incidence of treatment-emergent adverse events (TEAEs), with most being mild to moderate in severity and a low rate of serious TEAEs.
  • No specific safety concerns or adverse effects were detailed for tumor-induced osteomalacia (TIO) patients treated with burosumab in the provided studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Crysvita (burosumab) Prescribing Information.2020Ultragenyx Pharmaceutical Inc., Novato, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines