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# Crysvita BLA to be Submitted
- URL: https://www.fdaweb.com/crysvita-bla-to-be-submitted/
- Published: 2019-09-11T12:00:00.000Z
- Updated: 2026-09-15T01:49:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144979

Ultragenyx and Kyowa Kirin say they will submit a supplemental BLA to FDA for their Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that can’t be curatively resected or localized. The companies [say](https://www.marketwatch.com/press-release/ultragenyx-and-kyowa-kirin-announce-intent-to-submit-supplemental-biologics-license-application-to-us-fda-for-crysvitar-burosumab-in-tumor-induced-osteomalacia-tio-2019-09-10-9184311?ref=fdaweb.com) the decision to submit the sBLA follows a meeting with FDA and agreement on the filing package. The submission is planned for the first half of 2020 and will be based on the current clinical data package, they say.

Crysvita is approved by FDA for treating X-linked hypophosphatemia in adult and pediatric patients age one and older.