Date: 2012-03-02
Type of information:
Product name: desmoteplase
Compound: desmoteplase
Therapeutic area:
Action mechanism:
Company: Lundbeck (Denmark)
Disease: acute ischaemic stroke
Latest news: * On February 28, 2012, Lundbeck strengthens ownership of desmoteplase by acquiring Paion’s remaining rights for € 20.1 million.
Desmoteplase is currently under clinical phase III development for ischaemic stroke. More than half the patients in the phase III programme have been enrolled in two studies and the first study, DIAS-3, is expected to be completed in the first half 2013. Submission of MAA and NDA are expected in first half 2014.
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:
