First Quarter 2018 Investor Presentation
Investor Presentation
First three months of 2018
TresibaⓇ label in the USA updated based on DEVOTE trial
data
Lower rates of severe hypoglycaemia
demonstrated in DEVOTE trial
glargine U100
TresibaⓇ
•
-40%*
472
-27%*
252
187
280
Slide 12
FDA approved a label update for TresibaⓇ for
people with type 2 diabetes
Food and Drug Administration (FDA) approved updates to
the US prescribing information for TresibaⓇ to include data
from the DEVOTE trial including:
Cardiovascular safety based on TresibaⓇ demonstrated
non-inferiority compared to insulin glargine U100 with
regards to major adverse cardiovascular events¹ (MACE)
with a hazard ratio of 0.91
Statistically significant 40% reduction of severe
hypoglycaemic events compared to insulin glargine U100
The supplemental applications to include the two SWITCH
trials have been withdrawn following interactions with FDA
Subjects with one or more
severe events
Number of
overall severe events
Statistically significant
Source: Marso et al. New England Journal of Medicine 2017;377:723-32
1 MACE defined as first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke
changing
diabetes®
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