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: None *
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: Hypophosphatemia
Known Adverse Events: Back Pain | Dizziness | Headache | Pain Unspecified | Restless Legs Syndrome | Constipation
Company: Kyowa Hakko Kirin
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, France, Germany, Ireland, Italy, Japan, Spain, Sweden, United Kingdom
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Familial Hypophosphatemic Rickets|Hypophosphatemia, Familial|Osteomalacia|Rickets|Rickets, Hypophosphatemic|Tic Disorders
Phase 2: Hypophosphatemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2019-000469-19 | P2 |
Unknown status |
Tic Disorders|Rickets |
2025-03-03 |
|
| BUR-CL207 | P2 |
Completed |
Familial Hypophosphatemic Rickets|Rickets, Hypophosphatemic|Hypophosphatemia, Familial |
2023-10-04 |
24% |
| 2018-001983-49 | P2 |
Active, not recruiting |
Osteomalacia|Rickets|Hypophosphatemia |
2023-04-08 |
|
| BurGER | P3 |
Completed |
Hypophosphatemia, Familial|Rickets, Hypophosphatemic|Familial Hypophosphatemic Rickets |
2023-03-17 |