Investor Presentaiton
Investor presentation
Full year 2018
Slide 13
Oral semaglutide ready for regulatory filing following the
successful completion of the CV safety trial, PIONEER 6
•
Headline results for PIONEER 6
The trial met the primary endpoint¹ by demonstrating non-
inferiority of MACE with oral semaglutide compared to
placebo
Efficacy and safety profile of oral semaglutide was consistent
with the previous PIONEER trials
Headline results
MACE
CV death
HR
0.79
0.49*
All cause mortality
0.51*
Myocardial infarction, non-fatal
1.18
Stroke, non-fatal
0.74
Regulatory update for oral semaglutide
Oral semaglutide is expected to be filed around the end of
the first quarter 2019 by notifying the FDA that Novo
Nordisk will request priority review based on a priority
review voucher
Oral semaglutide is expected to be filed in the EU in first half
of 2019 and subsequently filed in Japan
Novo Nordisk is currently in a constructive dialogue with the
FDA to potentially obtain a CV indication for OzempicⓇ based
on the CVOTS SUSTAIN 6 and PIONEER 6 results
1 The primary endpoint was defined as the MACE composite outcome of the first occurrence of CV death,
non-fatal myocardial infarction or non-fatal stroke
Note: indicates statistical significance
CV: Cardiovascular, MACE: major adverse cardiovascular events, HR: hazard ratio
FDA: the Food and Drug Administration; CV: cardiovascular; CVOT: cardiovascular
outcomes trial
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