Thursday 29 January 2015

Amgen/Onyx file multiple myeloma drug in US, EU…..a supplemental New Drug Application has now been filed to support the conversion of this to full approval and expand target population.

Amgen/Onyx file multiple myeloma drug in US, EU…..a supplemental New Drug Application has now been filed to support the conversion of this to full approval and expand target population.


Carfilzomib.svg

Carfilzomib


supplemental New Drug Application filed
Amgen and its subsidiary Onyx Pharmaceuticals have submitted filings for their multiple myeloma drug Kyprolis (carfilzomib) on both sides of the Atlantic.
The companies are seeking approval to market their drug for the treatment of patents with relapsed multiple myeloma who have received at least one prior therapy.



Carfilzomib.svg
SYSTEMATIC (IUPAC) NAME
(S)-4-Methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide
CLINICAL DATA
TRADE NAMESKyprolis
LICENCE DATAUS FDA:link
PREGNANCY
CATEGORY
LEGAL STATUS
ROUTESIntravenous
IDENTIFIERS
CAS NUMBER868540-17-4
ATC CODEL01XX45
PUBCHEMCID 11556711
CHEMSPIDER9731489
KEGGD08880
CHEMBLCHEMBL451887
SYNONYMSPX-171-007
CHEMICAL DATA
FORMULAC40H57N5O7 
MOLECULAR MASS719.91 g mol

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