Date: 2011-09-27
Type of information: Granting of the orphan status in the US
Product name: dinaciclib
Compound: dinaciclib
Therapeutic area:
Action mechanism: kinase inhibitor. Dinaciclib blocks the action of cyclin-dependent kinases (CDK), which are involved in regulating the cell cycle. In order to become active, CDK has to attach to proteins called cyclns. In cancer cells, there are many of these cyclins and CDK becomes abnormally active leading to the growth and spread of cancer cells. By targeting CDK and blocking its action, dinaciclib is expected to interfere with the cell cycle of cancer cells in CLL and to bring about their death.
Company: Merck&Co (USA)
Disease: chronic lymphocytic leukemia
Latest news:
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2011-09-27
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: