Date: 2012-04-26
Type of information: Granting of the orphan status in the EU
Product name: PRO 001 - recombinant human methionine proinsulin
Compound: recombinant human methionine proinsulin
Therapeutic area: Ophtalmological diseases - Rare diseases
Action mechanism: protein. PRO 001 is a neuroprotective agent administered in a sustained-release formulation for the treatment of retinitis pigmentosa.This drug contains the proinsulin protein which is normally converted into insulin in the human body. In retinitis pigmentosa animal models, pro-insulin has delayed the death of the retinal cells and prolonged the visual function. This is expected to slow down and prevent the loss of retinal cells in those affected.
Company: ProRetina Therapeutics (Spain)
Disease: retinitis pigmentosa
Latest news: * On March 8, 2012, the COMP adopted positive opinion recommending recombinant human methionine proinsulin for treatment of retinitis pigmentosa 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: 2008-12-10
Orphan status UE: 2012-04-26
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
