Crysvita (burosumab)
- Region
- 🇪🇺 EU
- Active substance
- burosumab
- Company
- Kyowa Kirin Holdings B.V.
- Status
- Authorised
- Therapeutic area
- Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
- CHMP opinion
- Thu 14 Dec 2017
- EU approval
- Mon 19 Feb 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004275
- ATC
- M05BX05
- Official record
- www.ema.europa.eu
Indication
Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.