Burosumab-twza

(Crysvita®)

Crysvita®

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Drug updated on 5/17/2024

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.

Summary
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  • Burosumab-twza (Crysvita) is approved for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. It is also used for 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.
  • The information was derived from three systematic reviews/meta-analyses.
  • In terms of efficacy, burosumab demonstrates increased effectiveness over control groups by improving serum phosphorus levels, TmP/GFR, and 1,25-dihydroxyvitamin D levels among XLH patients. It also presents a promising non-surgical option for TIO cases where neoplasms cannot be localized or resected.
  • Regarding the safety profile comparison, burosumab has a safety profile not significantly different from control groups during randomized controlled trials on XLH treatments. Although there were high incidences of treatment-emergent adverse events (TEAEs), they were generally mild to moderate, with low rates of serious TEAEs reported.
  • Burosumab can benefit both pediatric and adult patients suffering from XLH, starting at an early age range - six months old onwards. Additionally, it has shown promise across various demographics, including men who are frequently affected by TIO, especially when surgical intervention is unsuccessful or unfeasible due to elevated FGF23 levels, indicating its potential use within precision medicine applications based on biomarker presence.
  • Compared to traditional treatments such as phosphate salts and calcitriol, typically used for managing symptoms related to XLH conditions, burosumab offers potentially superior efficacy through modulating underlying disease processes via action on FGF23 rather than just symptom management. For TIO, while surgical intervention remains the gold standard with a high success rate (>90%), burosumab provides an alternative for non-resectable tumors or unidentified neoplasms.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines