Overview
Burosumab (KRN23) is an entirely human monoclonal IgG1 antibody that binds excess fibroblast growth factor 23 (FGF23) and has been successfully tested in clinical trials in children with X-linked hypophosphatemic rickets . The U.S. Food and Drug Administration approved Crysvita (burosumab) in April 2018. This is the first drug approved to treat adults and children ages 1 year and older with X-linked hypophosphatemia (XLH), which is a rare, inherited form of rickets. X-linked hypophosphatemia causes low circulating levels of phosphorus in the blood. It causes impaired bone growth and development in children and adolescents and issues with bone mineralization throughout a patient’s life . XLH is a serious disease which affects about 3,000 children and 12,000 adults in the United States. Most children with XLH suffer from bowed or bent legs, short stature, bone pain and severe dental pain. Some adults with this condition suffer from persistent, unrelenting discomfort and complications, such as joint pain, impaired mobility, tooth abscesses and hearing loss .
Indication
This drug is indicated for the treatment of X-linked hypophosphatemia with radiological evidence of bone disease in children of 1 year of age and older and adolescents with growing skeletons .
Associated Conditions
- Hypophosphatemia
- X-Linked Hypophosphatemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/08/22 | Phase 2 | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | ||
2022/05/03 | Phase 4 | Completed | |||
2022/01/06 | N/A | Completed | |||
2021/04/12 | Phase 4 | Completed | |||
2021/04/12 | Phase 4 | Completed | |||
2021/01/05 | Phase 3 | Completed | |||
2020/06/05 | Phase 4 | UNKNOWN | Bicetre Hospital | ||
2020/03/25 | Phase 4 | Completed | |||
2020/03/13 | Phase 3 | Completed | |||
2019/12/06 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ultragenyx Pharmaceutical Inc. | 69794-304 | SUBCUTANEOUS | 30 mg in 1 mL | 6/23/2020 | |
| Kyowa Kirin, Inc. | 42747-102 | SUBCUTANEOUS | 10 mg in 1 mL | 11/17/2023 | |
| Kyowa Kirin, Inc. | 42747-304 | SUBCUTANEOUS | 30 mg in 1 mL | 11/17/2023 | |
| Ultragenyx Pharmaceutical Inc. | 69794-102 | SUBCUTANEOUS | 10 mg in 1 mL | 6/23/2020 | |
| Kyowa Kirin, Inc. | 42747-203 | SUBCUTANEOUS | 20 mg in 1 mL | 11/17/2023 | |
| Ultragenyx Pharmaceutical Inc. | 69794-203 | SUBCUTANEOUS | 20 mg in 1 mL | 6/23/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/19/2018 | ||
Authorised | 2/19/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CRYSVITA® SOLUTION FOR INJECTION 30 MG/ML | SIN16177P | INJECTION, SOLUTION | 30 mg/ml | 4/30/2021 | |
| CRYSVITA® SOLUTION FOR INJECTION 10 MG/ML | SIN16178P | INJECTION, SOLUTION | 10 mg/ml | 5/3/2021 | |
| CRYSVITA® SOLUTION FOR INJECTION 20 MG/ML | SIN16176P | INJECTION, SOLUTION | 20 mg/ml | 4/30/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Burosumab Injection | 国药准字SJ20210001 | 生物制品 | 注射剂 | 1/5/2021 | |
| Burosumab Injection | 国药准字SJ20210003 | 生物制品 | 注射剂 | 1/5/2021 | |
| Burosumab Injection | 国药准字SJ20210002 | 生物制品 | 注射剂 | 1/5/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CRYSVITA SOLUTION FOR INJECTION 30 MG/1ML | N/A | N/A | N/A | 4/20/2020 | |
| CRYSVITA SOLUTION FOR INJECTION 20 MG/1ML | N/A | N/A | N/A | 4/20/2020 | |
| CRYSVITA SOLUTION FOR INJECTION 10 MG/1ML | N/A | N/A | N/A | 4/20/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CRYSVITA burosumab 10 mg/mL solution for injection in a 5 mL vial | 340793 | Medicine | A | 9/10/2021 | |
| CRYSVITA burosumab 30 mg/mL solution for injection in a 5 mL vial | 340797 | Medicine | A | 9/10/2021 | |
| CRYSVITA burosumab 20 mg/mL solution for injection in a 5 mL vial | 340796 | Medicine | A | 9/10/2021 |
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