|
|
|
Burosumab (7)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
X-linked hypophosphataemia; ≥ 1 month to < 1 year
|
n.d.
|
active procedure
Orphan (turnover limit)
|
|
|
|
Burosumab (6)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
FGF23-related hypophosphatemia in tumour-induced osteomalacia
|
60–140
|
100%
additional benefit not proven
Orphan (turnover limit)
|
|
|
|
Burosumab (5)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
X-linked hypophosphatemia, ≥ 18 years of age
|
410–810
|
100%
additional benefit not proven
Orphan (turnover limit)
|
|
|
|
Burosumab (4)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
X-linked hypophosphatemia, ≥ 1 to < 18 years of age
|
200–550
|
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
|
|
|
|
Burosumab (3)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
X-linked hypophosphatemia (XLH), ≥ 18 years
|
0
410–810
|
100%
Hint for
minor additional benefit
Orphan
repealed
|
|
|
|
Burosumab (2)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
|
0
200–500
|
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
|
|
|
|
Burosumab (1)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
|
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
|
0
200–500
|
100%
non-quantifiable additional benefit
Orphan
repealed
|