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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.

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Carfilzomib.svg

Carfilzomib

 

synthesis………http://newdrugapprovals.org/2014/08/05/amgens-multiple-myeloma-drug-shows-promise-in-phase-3-trial/

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.

read all at…………http://www.pharmatimes.com/Article/15-01-28/Amgen_Onyx_file_multiple_myeloma_drug_in_US_EU.aspx

 

 

synthesis………http://newdrugapprovals.org/2014/08/05/amgens-multiple-myeloma-drug-shows-promise-in-phase-3-trial/

 

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 names Kyprolis
Licence data US FDA:link
Legal status
Routes Intravenous
Identifiers
CAS number 868540-17-4
ATC code L01XX45
PubChem CID 11556711
ChemSpider 9731489
KEGG D08880
ChEMBL CHEMBL451887
Synonyms PX-171-007
Chemical data
Formula C40H57N5O7 
Molecular mass 719.91 g mol

 


Filed under: sNDA Tagged: amgen, Carfilzomib, multiple myeloma, Onyx Pharmaceuticals, supplemental New Drug Application

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