Date: 2016-07-27
Type of information: Granting of the orphan status in the US
Product name: TNT009 - humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s
Compound: humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s
Therapeutic area: Rare diseases - Autoimmune diseases - Hematological diseases
Action mechanism:
- monoclonal antibody. TNT009 is a first-in-class monoclonal antibody that selectively inhibits the Classical Complement pathway by targeting C1s, a serine protease within the C1-complex in the Complement pathway of the immune system. TNT009 thereby prevents downstream disease processes involving phagocytosis, inflammation, and cell lysis. With a unique mechanism of action and high target specificity, TNT009 selectively inhibits disease processes in the classical complement pathway while maintaining the important immune surveillance provided by the Alternative complement pathway and lectin complement pathway.
- TNT009 is designed to selectively inhibit the classical complement pathway by targeting C1s and directly impacting the central mechanism of CAD. The only therapy in development that targets C1s, TNT009 has received orphan drug designation from the FDA and the European Medicines Agency. A number of other rare, complement-mediated diseases share the basic underlying pathological mechanism involving C1s that could potentially be addressed by TNT009.
Company: Assign Group Development UK (UK) Bioverativ (USA - CA)
Disease: autoimmune haemolytic anaemia
Latest news:
- • On July 27, 2016, the FDA has granted humanized IgG4 monoclonal antibody against total complement component 1, subcomponent s (C1s) ( TNT009) the orphan status for the treatment of autoimmune hemolytic anemia.
- • On January 27, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s for treatment of autoimmune haemolytic anaemia.
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: 2016-07-27
Orphan status UE: 2016-02-17
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
