Date: 2012-05-23
Type of information: Granting of the orphan status in the EU
Product name: Cyramza®
Compound: ramucirumab
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: monoclonal antibody. Ramucirumab is a fully human monoclonal antibody (IgG1) directed against the vascular endothelial growth factor receptor 2 (VEGFR2). By binding to VEGFR2 it works as a receptor antagonist blocking the binding of vascular endothelial growth factor (VEGF) to VEGFR2.
Company: Eli Lilly (USA - IN)
Disease: hepatocellular carcinoma
Latest news: * On May 11, 2012, the Committee for Orphan Medicinal Products (COMP) of the EMA has adopted a positive opinion recommending ramucirumab for designation as an orphan medicinal product for the treatment of hepatocellular carcinoma.
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: 2011-11-04
Orphan status UE: 2012-06-04
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
