Investor Presentaiton
Investor presentation
First three months of 2017
Slide 67
Fast-acting insulin aspart approved in the EU and Canada,
regulatory decision by FDA expected Q4 2017
•
Regulatory decisions and next steps
FiaspⓇ (fast-acting insulin aspart) launched in Germany, UK
and Canada
.
Next step: Launch roll-out in more European countries
• Class II resubmission of the NDA for fast-acting insulin
aspart in the US on 29 March 2017
FiaspⓇ vs NovoRapidⓇ EU label characteristics
Efficacy
Pharma-
cokinetics
Safety
•
Next step: Regulatory decision by the FDA expected Q4
2017
Specific
populations
•
FiaspⓇ HbA1c reduction of -0.32% compared
NovoRapidⓇ of -0.15% in type 1 diabetes patients
Fiasp® 1-h PPG reduction of -0.29 mmol/l
•FiaspⓇ twice as fast as NovoRapidⓇ
•Twice as much insulin available during first 30
minutes with FiaspⓇ
• Overall safety of FiaspⓇ consistent with NovoRapidⓇ
• Hypoglycaemia may occur earlier compared to
other mealtime insulins
•FiaspⓇ approved for pregnancy and pumps as
NovoRapidⓇ
Paediatric use not yet approved for FiaspⓇ and
more limited geriatric use vs NovoRapidⓇ
NDA: New drug application
changing
diabetes®
PPG: Postprandial glucose; SC: Subcutaneous
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