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▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.
Graph created based on the primary results of the NGENLA phase III study2
Open-label, multicenter, randomized, active-controlled, study in prepubertal children with GH deficiency to assess efficacy and safety of NGENLA once weekly versus GENOTROPIN® (somatropin) for injection once daily after 12 months of treatment.1,2
5 years of efficacy data from an open-label extension of a phase 2 study.1,3
Key findings over 5 years:
Phase 2, open-label, randomized, dose-finding, and safety study with yearly extension in prepubertal patients with GH deficiency. Fifty-three patients were randomized and treated with one of 3 doses of once weekly somatrogon (0.25 mg/kg/week [n=13], 0.48 mg/kg/week [n=15], or 0.66 mg/kg/week [n=14]) or GENOTROPIN administered once daily (0.034 mg/kg/day [n= 11]). Patients who completed 12 months of active treatment in the main study period remained eligible for inclusion in the open-label extension study. The open-label extension followed patients on NGENLA for up to 5 additional years; in years 2 and beyond, all patients were transitioned to NGENLA at 0.66 mg/kg/week.3,4
Ngenla▼ Prescribing Information
Genotropin Prescribing Information
Learn more about clinical safety data of NGENLA in children with GH deficiency.
Click here for more information on NGENLA once weekly dosing and administration.
Support for your patients throughout their treatment journey.
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PP-UNP-IRL-0176. January 2023