Date: 2016-08-29
Type of information: Granting of the orphan status in the EU
Product name: nintedanib
Compound: nintedanib
Therapeutic area: Rare diseases - Autoimmune diseases
Action mechanism: kinase inhibitor/tyrosine kinase inhibitor. Nintedanib is an orall small molecule tyrosine kinase inhibitor. This triple angiokinase inhibitor targets the three receptors crucially involved in angiogenesis and tumour growth: vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and beta), and fibroblast growth factor receptors (FGFR 1-3). All three receptors are crucially involved in the formation and maintenance of new blood vessels (angiogenesis).
Company: Boehringer Ingelheim (Germany)
Disease: systemic sclerosis
Latest news: * On 11-13 July, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for nintedanib for treatment of systemic sclerosis. A phase 3 trial is currently ongoing.
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: 2016-08-29
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
