Date: 2014-03-26
Type of information: Granting of the orphan status in the EU
Product name: eculizumab
Compound: eculizumab
Therapeutic area: Rare diseases
Action mechanism: monoclonal antibody. Eculizumab is a recombinant humanized monoclonal IgG2/4 antibody that specifically binds to the complement protein C5, inhibiting its cleavage by the C5 convertase which prevents the generation of the terminal complement complex C5b-9.
Company: Alexion Europe (France - EMEA service center of Alexion Pharmaceuticals (USA - CT)
Disease: prevention of delayed graft function after solid organ transplantation
Latest news: * On February 6, 2014, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for eculizumab for prevention of delayed graft function after solid organ transplantation.
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: 2014-01-10
Orphan status UE: 2014-03-26
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
