Date: 2017-09-29
Type of information: Granting of a Market Authorisation in the US
Product name: FIAsp® (faster-acting formulation of insulin aspart NovoRapid®) (NN1218)
Compound: insulin aspart
Therapeutic area: Metabolic diseases
Action mechanism:
- insulin analog. Faster-acting insulin aspart is a mealtime insulin for control of postprandial glucose excursions in type 1 and type 2 diabetes as well as in pump treatment. Faster-acting insulin aspart is insulin aspart (NovoRapid®) in a new formulation in which two new excipients have been added to ensure early and fast absorption. Fiasp® also has the option of a flexible dosing regimen (up to 20 minutes after starting a meal), without compromising overall glycaemic control, when compared to NovoRapid® dosed at mealtime.
Company: Novo Nordisk (Denmark)
Disease: diabetes
Latest news:
- • On September 29, 2017, Novo Nordisk announced that the FDA has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes.
- • On March 27, 2017, Novo Nordisk announced that Fiasp®, a new, fast-acting mealtime insulin for the treatment of diabetes in adults, has been launched in Canada, following the recent marketing authorisation from Health Canada on 6 January 2017.
- • On January 9, 2017, the European Commission has approved Fiasp® for the treatment of diabetes in adults.
- • On November 7-10, 2016, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for Fiasp® (insulin aspart) for the treatment of diabetes.
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: 2017-09-29
UE authorization: 2017-01-09
Favourable opinion UE: 2016-11-10
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
