Date: 2016-04-28
Type of information: Granting of the orphan status in the EU
Product name: C2N-8E12/ABBV-8E12 - recombinant humanized anti-tau antibody
Compound: recombinant humanized anti-tau antibody
Therapeutic area: Rare diseases - Neurodegenerative diseases - Neurological diseases
Action mechanism: monoclonal antibody. C2N-8E12 is a humanized antibody targeting the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as progressive supranuclear palsy and Alzheimer's disease. On March 19, 2015, AbbVie and C2N Diagnostics have entered into an exclusive worldwide license agreement to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer's Disease and other neurological disorders.
Company: C2N Diagnostics (USA - MO)/ Abbvie (USA - IL)
Disease: progressive supranuclear palsy
Latest news: * On March 25, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for humanised recombinant IgG4 anti-human tau antibody for treatment of progressive supranuclear palsy. * On January 22, 2015, the FDA has granted orphan drug designation for recombinant humanized anti-tau antibody for the treatment of progressive supranuclear palsy.
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: 2015-01-22
Orphan status UE: 2016-04-28
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
