Crysvita

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What is Crysvita (burosumab) for?

Crysvita (burosumab) is indicated for the treatment of:

• X-linked hypophosphatemia (XLH).
• Tumor-induced osteomalacia (TIO)

Approved presentations:

• 10 mg/mL in single dose vial
• 20 mg/mL in single dose vial
• 30 mg/mL in single dose vial

Where has Crysvita (burosumab) been approved?

Crysvita (burosumab) has been approved for the treatment of:

• X-linked hypophosphataemia (XLH) in adult and pediatric patients 6 months of age and older, by
  • The Food and Drug Administration (FDA) on April 17, 2018.
  • The European Medicines Agency (EMA) on February 19, 2018.
  • Health Canada on December 06, 2018.
• Tumor-induced osteomalacia (TIO), by
  • The FDA on June 18, 2020.
  • Health Canada on September 07, 2021.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about it’s approval in a specific country feel free to contact our support team.

References

Please see full prescribing information and available presentations at:

1. Prescribing Information (FDA): Crysvita (burosumab) [PDF], Kyowa Kirin, 2018.

2. Summary of Product Characteristics (EMA): Crysvita (burosumab) [PDF], Kyowa Kirin, 2018