Date: 2012-04-06
Type of information:
Product name: linsitinib
Compound: linsitinib
Therapeutic area:
Action mechanism:
Company: Astellas (Japan)
Disease: adrenal cortical carcinoma
Latest news: * On 7-8 February 2012 the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for linsitinib for treatment of adrenal cortical carcinoma. A phase 3 study is ongoing in Australia, Canada, France, Germany, Italy, The Netherlands, Poland, UK and USA.
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:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
