Investor Presentaiton
Investor presentation
ADA 2019
Slide 33
Oral semaglutide filed in the USA, the EU and Canada, and
OzempicⓇ CV risk reduction indication filed in the USA
Expected timelines for the FDA review
Q1 2019 | Q2 2019 | Q3 2019 | Q4 2019 | Q1 2020
Oral semaglutide
Expected review time: 6 months
Oral semaglutide (CV indication)
Expected review time: 10 months
Ozempic® (CV indication)
Expected review time: 10 months
Oral semaglutide filed in key markets
Three FDA filings:
. NDA for oral semaglutide for glycaemic control
.
NDA for oral semaglutide CV indication
. SNDA for Ozempic® CV indication
Regulatory filing in the EU for oral semaglutide for
type 2 diabetes treatment
Regulatory filing in Canada for oral semaglutide for
type 2 diabetes treatment
CV: Cardiovascular; FDA: the US Food and Drug Administration; Q: Quarter; NDA: New Drug Application; SNDA: Supplementary New Drug Application
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