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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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Prescribing Information for NGENLA▼(somatrogon) can be found here. Prescribing Information for Genotropin (somatropin) can be found here. Adverse event reporting information can be found at the bottom of the page.

Data supporting the efficacy and safety profile of NGENLA

Clinical Trial Programme Overview

​​​​​​

Phase

Study

Methodology

Treatment duration

Phase 3

Definitive safety and efficacy study
​​​​​​​​​​​​​​1

Open-label, multi-centre, randomised, active-controlled, parallel-group, non-inferiority study in prepubertal children with Growth Hormone deficiency. Patients were randomised to weekly doses of NGENLA (0.66 mg/kg/week; n=109) or daily administration of GENOTROPIN (somatropin) (0.034 mg/kg/day; n=115). [Total sample: N=224]

12 months

 ​​​​​​​

Phase 3 extension

Open Label Extension (OLE) definitive safety and efficacy study
​​​​​​​​​​​​​​1,2

Patients who completed the main study were eligible for inclusion. Those who received NGENLA in the main study continued to receive NGENLA once weekly at the same dose (0.66mg/kg/wk) while patients who received GENOTROPIN in the main study were switched to NGENLA once weekly (0.66mg/kg/wk). [Total sample: N=212]

Ongoing (12 months of data available)

Phase 3 Treatment Budren Study

Treatment burden crossover study​​​​​​​1,3​​

Open-label, multi-centre, 2 period, crossover assessing patient perception of treatment burden. Patients were randomised in a 1:1 ratio to either 12 weeks of NGENLA once-weekly followed by 12 weeks of GENOTROPIN once daily, or 12 weeks of GENOTROPIN once daily followed by 12 weeks of NGENLA once weekly. [Total sample N=87]

24 weeks (12 weeks per treatment arm)

Phase 2

Safety, tolerability and dose-finding  study4

Open label, randomised, active-controlled study comparing three dose levels of NGENLA administered weekly to daily Growth Hormone (GENOTROPIN 0.034 mg/kg/day) [Total sample: N=53]

12 months

Phase 2 extension

OLE efficacy and safety study​​​​​​​5

Open label, randomised, multi-centre, dose finding, and safety study of different NGENLA dose levels in pre-pubertal Growth Hormone Deficiency patients with yearly extension until marketing approval. In extension year 1, patients taking NGENLA continued their assigned dose. Patients taking GENOTROPIN were assigned to 1 of 3 NGENLA doses. In extension years 2 and beyond, patients were transitioned to NGENLA (0.66 mg/kg/week). [Total sample: N=48

Ongoing (48 months of data available)

Annual height velocity non-inferior to Genotropin (somatropin)​​​​​​​

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

Mean & median IGF-1 values normalised at 1 month of treatment​​​​​​​*​​

Post-hoc analysis of IGF-1 SDS profiles over the dosing interval during 12 months of treatment with NGENLA.6

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.

Safety profile​​​​​​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 reproted 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.
​​​​​​​

System Organ Class

Very Common

Common

Uncommon

​​​​​​​Blood and Lymphatic System Disorders

Anaemia
​​​​​​​Eosinophilia

​​​​​​​Endocrine Disorders

Hypothyroidism

Adrenal Insufficiency

​​​​​​​Nervous system disorders

Headache

​​​​​​​Eye Disorders

Conjunctivitis allergic

Skin and subcutaneous tissue disorders

Arthralgia
Pain in extremity

Rash generalised

General Disorders and Administration site conditions

Injection site reactions​​​​​​​a​​​​​​​ 
​​​​​​​
Pyrexia

Data is available on the phase 3 crossover study versus daily GH, based upon life interference score and a range of life intereference score parameters, which indicated that NGENLA may deliver a favoured treatment experience for patients and caregivers.​​​​​​​3  Click here to find out more.


An introduction to Weekly NGENLA and its Mode of Action.

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The NGENLA team are here to support you with any queries. Find out how you can get in touch.

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The Formulary Pack is available to download. Find out more information here.

Formulary Pack


References:
​​​​​​​
1. ​​NGENLA Summary of Product Characteristics for Great Britain: https://www.medicines.org.uk/emc/search?q=ngenla & Northern Ireland: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=4319e9d0-5396-4363-8dcb-bc72051b39da&type=smpc
2. Wajnrajch M, Miller BS, Steelman J, et al. Switch data from the open-label extension of the pivotal phase 3 study of once weekly Somatrogon compared with daily Somatropin in pediatric patients with growth hormone deficiency (GHD). Poster 7129 presented at: Annual Meeting of the Endocrine Society [virtual]; March 20-23, 2021.
 3. Maniatis AK, Carakushansky M, Galcheva S, et al. Perception of treatment burden with once weekly Somatrogon vs once daily Genotropin in pediatric patients with growth hormone deficiency: results from a randomized phase 3 study. Poster 6895 presented at: Annual Meeting of the Endocrine Society [virtual]; March 20-23, 2021.
 4. Zelinska N, Iotova V, Skorodok J, et al. Long-acting C-terminal peptide–modified hGH (MOD-4023): results of a safety and dose-finding study in GHD children. J Clin Endocrinol Metab. 2017;102(5):1578‐1587.
 5. Zadik Z, Zalinska N, Iotova V, et al. Results from an open-label extension of the phase 2 dose-finding study of once weekly Somatrogon vs daily Genotropin in pediatric patients with growth hormone deficiency (GHD). Poster 6887 presented at: Annual Meeting of the Endocrine Society [virtual]; March 20-23, 2021.
 6. Pfizer Data on File: PP-NGE-GBR-0047.

​​​​​​​
PP-NGE-GBR-0035. May 2022.

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