Product Description
Burosumab-twza injection is used to treat X-linked hypophosphatemia (XLH; an inherited disease where the body doesn't maintain phosphorus and that leads to weak bones) in adults and children 6 months of age and older. It is also used to treat tumor-induced osteomalacia (a tumor that causes a loss of phosphorus in the body that leads to weak bones) that cannot be surgically removed in adults and children 2 years of age and older, Burosumab-twza injection is in a class of medications called fibroblast growth factor 23 (FGF23) blocking antibodies. It works by blocking the action of a certain natural substance in the body which causes the symptoms of XLH. (Sourced from: https://medlineplus.gov/druginfo/meds/a618034.html)
Mechanisms of Action: FGF23 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Peru | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Kyowa Hakko Kirin
Company Location:
Company Founding Year: 1949
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, France, Germany, Italy, Japan, Spain, Sweden, United Kingdom
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- PDUFA summary: FDA accepted review of Crysvita for TIO with PDUFA target date set for June 18, 2020, prioritizing patient access.
Highest Development Phases
Phase 3: Familial Hypophosphatemic Rickets|Hypophosphatemia, Familial|Osteomalacia|Rickets, Hypophosphatemic
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04188964 |
BUR-CL207 | P2 |
Completed |
Rickets, Hypophosphatemic|Hypophosphatemia, Familial|Familial Hypophosphatemic Rickets |
2023-10-04 |
50% |
2024-05-04 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
JapicCTI-205284 |
JapicCTI-205284 | P3 |
Active |
Osteomalacia|Rickets, Hypophosphatemic |
2020-12-31 |
|||
NCT04695860 |
BurGER | P3 |
Completed |
Familial Hypophosphatemic Rickets|Rickets, Hypophosphatemic|Hypophosphatemia, Familial |
2023-03-17 |
2023-07-22 |
Primary Endpoints|Treatments |