Type of information: Acceptation for review of a NDA
Product name: sotagliflozin (LX4211)
Therapeutic area: Metabolic diseases
- SGLT1 inhibitor/SGLT2 inhibitor. Sotagliflozin is an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2) that influence how the intestines and kidneys process glucose.
- The product has been developed in partnership with Lexicon Pharmaceuticals.
Company: Sanofi (France)
Disease: type 1 diabetes
- • On March 29, 2018, the European Medicines Agency (EMA) has accepted for review Sanofi’s regulatory submission for sotagliflozin. If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus. The Marketing Authorization Application is based on data from the inTandem clinical trial program which consists of three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: