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Crysvita FDA Approval History

FDA Approved: Yes (First approved April 17, 2018)
Brand name: Crysvita
Generic name: burosumab-twza
Dosage form: Injection
Company: Ultragenyx Pharmaceutical Inc.
Treatment for: X-Linked Hypophosphatemia; Tumor-Induced Osteomalacia

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH) and FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO).

Development Timeline for Crysvita

DateArticle
Jun 18, 2020Approval Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)
Sep 30, 2019Approval FDA Approves Label Update for Crysvita (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) in Pediatric Patients 6 Months of Age and Older
Apr 17, 2018Approval FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
Oct 10, 2017Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab Biologics License Application
Aug 24, 2017Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab Biologics License Application in the US

Further information

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