Investor Presentation First Nine Months of 2023
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Investor presentation
First nine months of 2023
Novo NordiskⓇ
In the Explorer 7 trial, concizumab reduced the number of bleeds
in adults and adolescents with inhibitors
Explorer 7 trial results: Annualised bleeding rate per patient group
Annualised Bleeding Rate (ABR)
100
90
40
40
30
20
20
Median Mean
Efficacy
•
Key highlights
Median ABR was 0 for concizumab prophylaxis treatment, compared
to 9.8 in the on-demand treatment group
Estimated mean ABR was 1.7 for concizumab prophylaxis treatment,
compared to 11.8 in the on-demand treatment group
For patients on concizumab prophylaxis, 64% had 0 bleeds in Group 2
Safety
Concizumab appeared to have a safe and well tolerated profile
10
9.8
OnD treatment PPX treatment PPX treatment
HWI
(Group 1)
HWI
(Group 2)
HAWI
(Groups 1-4)
0
PPX treatment
HBWI
(Groups 1-4)
Status
US Complete Response Letter for HwI received in Q2 2023,
resubmission during 2024 expected
Approved in: Canada (HAwI/HBwI), Australia (HAwI/HBWI), Switzerland
(HAWI/HBWI) and Japan (HAWI/HBWI)
Explorer8 in non-inhibitor patients was completed in Q3 2022
Primary endpoint
Note: The box represents Q1-Q3 (25th to 75th percentile). Whiskers are 5th and 95th percentile.
HA: Haemophilia A; HB: Haemophilia B; HAWI: Haemophilia A with inhibitors, HBwI: Haemophilia B with inhibitors; HwI: Haemophilia with inhibitors; OnD: On-demand; PPX: Prophylaxis; ABR annualised bleeding rateView entire presentation