Date: 0000-00-00
Type of information: Granting of the orphan status in the EU
Product name: OPN-305
Compound: humanised IgG4 monoclonal antibody to the human toll-like receptor type 2
Therapeutic area: Rare diseases - Cancer - Oncology
Action mechanism: monoclonal antibody. OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a target within the innate immune system. OPN-305 has also orphan status in the EU and USA for solid organ transplantation.
Company: Opsona Therapeutics (Ireland)
Disease: myelodysplastic syndromes
Latest news:
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: 2016-08-30
Orphan status UE: 2017-02-27
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: