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Home Industry News Novo Nordisk receives EU approval for diabetes drug Fiasp

Novo Nordisk receives EU approval for diabetes drug Fiasp

11th January 2017

Novo Nordisk has announced that its new diabetes therapy Fiasp has been approved by the European Commission.

The regulatory body has approved the fast-acting insulin aspart therapy for use in the treatment of type 1 and type 2 diabetes among adult patients, with product launches planned in several European countries in the first half of this year.

A phase III clinical programme consisting of four trials encompassing more than 2,100 participants showed that Fiasp can provide improved mealtime and overall glucose control, with a similar safety profile to the older insulin aspart treatment NovoRapid.

Fiasp represents an advanced insulin aspart formulation compared to NovoRapid, with two new excipients added to ensure earlier, greater and faster absorption, therefore providing earlier insulin action.

The drug will be available for use through vial, Penfill and FlexTouch pen-based administration.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "The incremental benefits with Fiasp are comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago."

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