Date: 2017-06-15
Type of information: Positive opinion for the granting of the orphan status in the EU
Product name: recombinant human antibody directed against misfolded human superoxide dismutase 1
Compound: recombinant human antibody directed against misfolded human superoxide dismutase 1
Therapeutic area: Rare diseases - Neurodegenerative diseases
Action mechanism:
Company: The Medical & Regulatory Partnership (UK)
Disease: amyotrophic lateral sclerosis
Latest news: • On June 15, 2017 , the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for recombinant human antibody directed against misfolded human superoxide dismutase 1 for treatment of amyotrophic lateral sclerosis.
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:
