close

Products

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:

  • • On January 19, 2017, the Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending  humanised IgG4 monoclonal antibody to the human toll-like receptor type 2 for designation as orphan medicinal product to the European Commission for the treatment of myelodysplastic syndromes.
  • • On August 30, 2016, Opsona Therapeutics has received orphan drug designation from the FDA for myelodysplastic syndromes. A study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston.
 

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:

Is general: Yes