Investor Presentation Full Year 2021
77
Investor presentation Full year 2021
Novo NordiskⓇ
Once-weekly, biodegradable somapacitan has successful
completed phase 3 for GHD and is approved for AGHD indication
Mean
height velocity
(cm/year)
16
14
12
10
8
6
Phase 2 trial in GHD with 1-year efficacy and safety
*
11.5
10.01
9.7
7.8
4
2
0
0.04
0.08
0.16
0.034
Somapacitan
(mg/kg/week)
Norditropin®
(mg/day)
Somapacitan
Growth hormone with a
single amino acid
substitution
•
•
Next steps
Albumin binding side
chain securing
Somapacitan in children (GHD)
reversible binding to
endogenous albumin
Phase 3 trial (REAL 4) has been successfully
completed
Somapacitan dose 0.16 mg/kg/week
Somapacitan in children (SGA)
• Phase 2 trial (REAL 5) has been initiated
Somapacitan in adults (AGHD)
• Has been approved in the US, Japan and the EU
under the tradename Sogroya®
Data are mean height velocity (cm/year) ± SD at week (wk) 52. Doses are mg/kg/time. * Denotes statistical significance difference compared to once-daily NorditropinⓇ. GHD: Growth hormone deficiency;
AGHD: Adult-onset growth hormone deficiency; FDA: Food and Drug Administration; EMA; European Medicines Agency; Value was 9.8 for the full analysis set. Value of 10.0 is from a post-hoc analysis that
excluded 4 visits of one patient who discontinued prematurely at week 6View entire presentation