Burosumab (6) – Crysvita®
FGF23-related hypophosphatemia in tumour-induced osteomalacia
Characteristics
| Start date | 01.09.2022 – Marketing authorisation: 25.07.2022 |
|---|---|
| Resolution | 16.02.2023 |
| INN | Burosumab |
| Brand name | Crysvita® |
| Pharm. company | Kyowa Kirin GmbH |
| G-BA Procedure ID | D-852 |
| ATC code | M05BX05 Other drugs affecting bone structure and mineralization (M05BX) |
| ICD-10 codes (AIS) | E83.38, M83.89 |
| Alpha-ID codes (AIS) | I128133Oncogenic osteomalacia, I65880Acquired hypophosphatemia |
| ORPHAcodes (AIS) | 352540Oncogenic osteomalacia, |
| DDD | 2.5 mg P |
| Therapeutic area | Metabolic diseases Hypophosphatemia Orphan (turnover limit) |
| Reason for procedure | New therapeutic indication – Orphan turnover exceeded |
| Therapeutic indication of the resolution |
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|
Crysvita is used for the treatment of FGF23-related hypophosphatemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumors that cannot be curatively treated by surgery or cannot be localised, in children and adolescents aged 1 to 17 years, and in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients 1 year and older with FGF23-related hypophosphatemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively treated by surgery or cannot be localised. | A phosphate substitution and active vitamin D (calcitriol or alfacalcidol) in combination |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: Single-arm + no comparison) |
- Clinical trials
- To assess the additional benefit of buurosumab for patients aged 1 year and over with FGF23-related hypophosphataemia in tumour-induced osteomalacia (TIO), associated with phosphaturic mesenchymal tumours that cannot be curatively treated by surgery or cannot be localised, the pharmaceutical manufacturer submitted the two open-label, single-arm Phase II studies UX023T-CL201 and KRN23-002, which formed the basis for the marketing authorisation.
- The single-arm study UX023T-CL201 included adult patients with TIO as well as patients with osteomalacia associated with epidermal naevus syndrome (ENS).
- A total of 14 adult patients with TIO were enrolled in the single-arm study KRN23-002.
Patients aged 1 year and over with FGF23-related hypophosphataemia in tumour-induced osteomalacia, associated with phosphaturic mesenchymal tumours that cannot be curatively treated by surgery or cannot be localised
- The additional benefit is not proven.
- An additional benefit of burosumab compared with the appropriate comparator therapy is not proven.
- Burosumab may represent a relevant treatment option in individual cases within the present therapeutic indication.
- Overall, the pharmaceutical manufacturer did not submit any study for this therapeutic indication that would have been suitable for assessing the additional benefit of Burosumab compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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