Investor Presentation - First Six Months of 2021
81
Investor presentation
First six months of 2021
Novo NordiskⓇ
Semaglutide showed significant improvements in NASH
resolution and could play a role in preventing disease progression
Proportion
of patients
100%
Semaglutide showed resolution of NASH with no worsening of
fibrosis versus placebo in the phase 2 trial1
80%
60%
40%
22.9%
20%
0%
Placebo
*
*
47.3%
46.9%
0.2 mg
0.1 mg
66.7%*
NASH resolution without worsening of
fibrosis is one of two critical endpoints
defined by the FDA and EMA²
For prevention of NASH disease progression,
NASH resolution could be the more relevant
endpoint
To date, semaglutide NASH results are
arguably the most convincing NASH
resolution data shown
Semaglutide in NASH was granted
Breakthrough Therapy designation in the US
Phase 3 programme initiated in 2021
0.4 mg
*statistically significant at 72 weeks (p<0.05 vs placebo). Based on a complete case analysis using people with an evaluable biopsy at end of trial
1 Analysis included patients with fibrosis stage 1, 2 or 3 at baseline
2 FDA guidance on developing treatment for NASH: "Noncirrhotic Non-alcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Guidance for Industry". EMA guidance on developing treatment for NASH: "Reflection paper on regulatory
requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)"
NASH: non-alcoholic steatohepatitis.View entire presentation