Investor Presentation First Nine Months of 2023
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Investor presentation
First nine months of 2023
SogroyaⓇ was approved for paediatric growth hormone
deficiency in US, EU and Japan in Q2 2023
Phase 3a trial results in children with GHD
ETD (95% CI) = -0.5 (-1.1; 0.2)
Efficacy
Key highlights
Height velocity (cm/year)
12.5
11.7
10.0
7.5
5.0
2.5
0.0
NorditropinⓇ
.
Non-inferiority versus NorditropinⓇ for the primary endpoint, height
velocity, at week 52 was confirmed
11.2
•
IGF-I SDS, bone age and glucose metabolism were all similar
between somapacitan and NorditropinⓇ
Safety and tolerability
•
Overall the safety profile of somapacitan appeared to be similar to
the well-known safety profile of daily GHD treatment
•
No local tolerability issues were identified
Other treatment parameters
•
Significantly reduced treatment burden¹ compared to Norditropin®
Status
•
Adult GHD: Approved by the US, EU and JP
somapacitan
•
Paediatric GHD: Approved by the US, EU and JP
1 Measured using patient reported outcome TB-CGHD-P (Treatment burden measure - child growth hormone deficiency - parent)
ETD: Estimated treatment difference; IGF-I SDS: Insulin growth factor-1 standard deviation score; GHD: Growth hormone deficiency; IGF-I SDS: Insulin growth factor-1 standard deviation score; US: United States; EU: European Union; JP: Japan
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