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Status:
US Approved Rx
(2021)
Source:
BLA761195
(2021)
Source URL:
First approved in 2021
Source:
BLA761195
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761208
(2021)
Source URL:
First approved in 2021
Source:
BLA761208
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761178
(2021)
Source URL:
First approved in 2021
Source:
BLA761178
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761166
(2021)
Source URL:
First approved in 2021
Source:
BLA761166
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761194
(2021)
Source URL:
First approved in 2021
Source:
BLA761194
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761174
(2021)
Source URL:
First approved in 2021
Source:
BLA761174
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761181
(2021)
Source URL:
First approved in 2021
Source:
BLA761181
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
NDA214938
(2021)
Source URL:
First approved in 2021
Source:
NDA214938
Source URL:
Class:
PROTEIN
Conditions:
Vosoritide (VOXZOGO®; BMN-111) is a modified recombinant human C-type natriuretic peptide (CNP) analogue, being developed by BioMarin Pharmaceutical for the treatment of achondroplasia. Achondroplasia is caused by a gain-of-function mutation in the fibroblast growth factor receptor 3 gene (FGFR3), which is a negative regulator of bone growth. Vosoritide acts to restore chondrogenesis through its binding to natriuretic peptide receptor B (NPR-B), resulting in the inhibition of downstream signalling pathways of the overactive FGFR3 gene. Vosoritide was approved in August 2021 in the EU for the treatment of achondroplasia in patients aged ≥ 2 years whose epiphyses are not closed; the diagnosis of achondroplasia should be confirmed by appropriate genetic testing. In November 2021, Voxzogo was also approved by FDA to improve growth in children with achondroplasia.
Status:
US Approved Rx
(2021)
Source:
BLA761224
(2021)
Source URL:
First approved in 2021
Source:
BLA761224
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761180
(2021)
Source URL:
First approved in 2021
Source:
BLA761180
Source URL:
Class:
PROTEIN