Date: 2012-03-26
Type of information: Granting of the orphan status in the EU
Product name: ombrabulin
Compound: ombrabulin
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: Ombrabulin is derived from combretastatin, a natural substance extracted from a bark of a South African tree. It is expected to work in soft tissue sarcoma mainly by disrupting the vessels that bring blood to the tumour, blocking the normal flow of the blood. Ombrabulin is a tubulin-binding agent that targets the immature neovasculature of tumors. Ombrabulin is also expected to disrupt the division of cancer cells by attaching to a protein in cells called ‘tubulin’, which is important in the formation of the internal ‘skeleton’ that cells need to assemble when they divide.
Company: Sanofi (France)
Disease: soft tissue sarcoma
Latest news: * On January 11-12, 2011, the Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending ombrabulin for treatment of soft tissue sarcoma, for designation as orphan medicinal products to the European Commission.
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: 2011-04-15
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
