Date: 2015-07-28
Type of information: Granting of the orphan status in the EU
Product name: human plasminogen
Compound: human plasminogen
Therapeutic area: Rare diseases - Genetic diseases
Action mechanism: glycoprotein
Company: ProMetic BioTherapeutics (Canada)
Disease: plasminogen deficiency
Latest news: * On 16-18 June, 2015, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending human plasminogen for designation as orphan medicinal product for treatment plasminogen deficiency. A phase 1 study is currentyly ongoing in the US. (NCT02312180)
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: 2013-03-05 (hypoplasminogenemia, or type I plasminogen deficiency)
Orphan status UE: 2015-07-28
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
