Efficacy demonstrated non-inferiority to daily Genotropin at 1 year (N=224) ¹
95% CI [-0.24 to 0.89]

Study Design: Open-label, multicentre, randomised, active-controlled, noninferiority study in prepubertal children with GH deficiency to assess efficacy and safety of NGENLA once weekly versus GENOTROPIN once daily after 12 months of treatment.¹

Once-weekly NGENLA delivered sustained growth and maintained a consistent safety profile over 8 years 5,6,7

Key findings over 8 years: 

• 91% of patients (N=48) chose to continue in the Phase 2 open label extension when given the choice to continue with somatrogon ⁵
• Following up to 8 years of somatrogon treatment, including 7 years of open label extension, subjects demonstrated continued growth, 4 achieved final height, and somatrogon maintained a consistent safety profile ⁵
• Progressive gains in height velocity SDS were achieved ⁵

•  In Year 1 there was 3 different NGENLA doses and 1 dose of Genotropin. 
• In Year 2, those patients taking NGENLA remained on their original dose, and Genotropin recipients were randomised to one of the three NGENLA doses. 
• From Year 3, all patients received 0.66 mg/kg/week of NGENLA. 
• Graph does not include Year 5 data as most patients switched from single-use vials to a multi-dose pen during this year. Only 1 patient completed the whole of Year 5 using single-use vials. 

• Incidence of TEAEs was lower than in Years 1-7 (range: 41.9-71.4%).
• No serious TEAEs or TEAEs leading to somatrogon withdrawal occurred. 
• Treatment - related TEAEs occurred in 2 subjects: keeled chest acquired and scoliosis (n=1) and arthalgia (n=1). 

Post-hoc analysis of IGF-1 SDS profiles over the dosing interval during 12 months of treatment with NGENLA. ⁸

The mean and median of the modelled mean IGF-1 SDS values gradually increased in the first 6 months of the study and remained stable thereafter. IGF-1 should be monitored regularly to ensure that levels remain within the normal range. In patients whose serum IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of somatrogon should be reduced by 15%. More than one dose reduction may be required in some patients.¹

*Based on observed (predose) or modelled 4 days postdose mean values.
​​​​​IGF-1, insulin-like growth factor 1; SD, standard deviation.

• Samples collected on day 2 or 3 will overestimate average IGF-1
• Samples collected on day 4 (96hrs) will best estimate average IGF-1
• Samples collected on day 5, 6 or 7 will underestimate average IGF-1

Safety data are derived from the phase 2, multi-centre safety and dose-finding study, and the pivotal phase 3, multi-centre non-inferiority study in paediatric patients with Growth Hormone Deficiency. The data reflect exposure of 265 patients to NGENLA administered once weekly (0.66mg/kg/week).
 

In the phase 2, multi-centre safety and dose-finding study, 31 patients received up to 0.66mg/kg/week of NGENLA for up to 7.7 years.
 

The commonly reported adverse reactions after treatment with NGENLA are injection site reactions (ISRs) (25.1%), headache (10.7%) and pyrexia (10.2%).
 

For full information and description of selected adverse reactions refer to the Summary of Product Characteristics for NGENLA.
 

Very common (≥ 1/10); Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very Rare (< 1/10,000) or frequency not known (cannot be estimated from the available data).
 

There are no reactions reported to date in the Rare, Very Rare and Frequency not known categories.
 

a - Injection site reactions include the following: injection site pain, erythema, pruritus, swelling, induration, bruising, haemorrhage, warmth, hypertrophy, inflammation, deformation, urticaria.
 

Efficacy and safety of weekly somatrogon vs daily somatropin in children with growth hormone deficiency: a phase 3 study.

The incidence of treatment-emergent adverse events (TEAEs) was similar between the somatrogon (87.2%) and somatropin groups (84.3%).

Study Design: Open-label, multicentre, randomised, active-controlled, noninferiority study in prepubertal children with GH deficiency to assess efficacy and safety of NGENLA once weekly versus GENOTROPIN once daily after 12 months of treatment.¹

Patients were randomised to weekly doses of NGENLA (0.66mg/kg/week; n=109) or daily administration of GENOTROPIN (somatropin (0.034mg/kg/day; n=115. Total sample: N=224).

Adapted from Deal et al., 2022.

Serious AEs are based on the investigator's assesment. No deaths occured during the study. 
Abbreviation: AE, adverse event.
^a Subjects who have an AE record that indicates that the AE caused the subject to be discontinued from the study.

All-causality TEAEs with ≥5% higher incidence in the somatrogon group than in the somatropin group were injection site erythema, injection site pain and injection site pruritus.

Study Design: Open-label, multicentre, randomised, active-controlled, noninferiority study in prepubertal children with GH deficiency to assess efficacy and safety of NGENLA once weekly versus GENOTROPIN once daily after 12 months of treatment.¹