NGENLA is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone (GH).

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.

Once-weekly NGENLA delivered sustained growth and maintained a consistent safety profile over 8 years ^4,5,6

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 ⁴
• 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 ⁴
• Progressive gains in height velocity SDS were achieved ⁴

Data above: Year 1 is the main Phase 2 study (duration 12 months). Year 2 onwards is the Phase 2 extension study. Data adapted from Pfizer data on file: PP-NGE-GBR-0851 and PP-NGE-GBR-0421.
SDS: standard deviation scores

Data limitations

The first three years of this trial were the dose trialling portion so used unlicensed doses. Therefore, the full data from these years cannot be presented. Data are shown only for the cohort taking the approved dose of NGENLA 0.66 mg/kg/week.

• 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. 

• In Year 8, 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). 
• Following up to 8 years of treatment with NGENLA, patients demonstrated continued growth. 

Homecare:
We offer an at home medication delivery service and face to face nursing support through a range of providers.

• Free and flexible home delivery service of NGENLA
• Standard Homecare service: up to 2 face-to-face or virtual home nurse visits

Starter Kit:
Each NGENLA starter kit contains*:

• Box of swabs
• Sharps bin
• Box of needles