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Somapacitan (Sogroya) - for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD) somapacitan (Sogroya®) subcutaneous injection Novo Nordisk Ltd February 2022 Statement of Advice In the absence of a submission from the holder of the marketing authorisation, somapacitan (Sogroya ®) cannot be endorsed for use within NHS Wales
Somapacitan (Sogroya) - growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]) Return to Article DetailsSomapacitan (Sogroya)
Somapacitan (Sogroya) - Growth hormone deficiency View of Somapacitan (Sogroya) | Canadian Journal of Health TechnologiesReturn to Article DetailsSomapacitan (Sogroya)
Somapacitan for treating idiopathic short stature or Noonan syndrome or small for gestational age in people aged 2 to 18 years Somapacitan for treating idiopathic short stature or Noonan syndrome or small for gestational age in people aged 2 to 18 years - NIHR Innovation Observatory * Who we are * What we do * Our Networks * Engage * Events * News * Resources Get in touch * * A world leading MedicinesApril 2024 IO Dashboards Obesity MedicinesMarch 2024 * Who we are * Meet the Team * Our Mission * Our Values * What we do * Emerging horizon * Transitional horizon * Imminent horizon * Our Networks * Our Stakeholders * Our Work with NICE * Health & Life Sciences Ecosystem * Engage * Industry * Public Involvement * Capacity Building * Events * News * Resources * Contact 25 June 2024 Somapacitan
Somapacitan (Sogroya) - for the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult G Published 11 November 2024 Advice document SMC2629 somapacitan solution for injection in pre-filled pen (Sogroya®) Novo Nordisk 04 October2024 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated submission somapacitan (Sogroya®) is accepted for restricted use within NHSScotland. Indication under review
Somapacitan-beco (Sogroya) - Growth hormone Drug Approval Package: SOGROYA * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines
Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial. Somapacitan is a long-acting growth hormone (GH) derivative developed for the treatment of GH deficiency (GHD). This study evaluates the efficacy and tolerability of somapacitan in Japanese children with GHD after 104 weeks of treatment and after switch from daily GH. Subanalysis on Japanese patients from a randomised, open-labelled, controlled parallel-group phase 3 trial (REAL4, NCT03811535). Thirty treatment-naïve patients were randomised 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) up to Week 52, after which all patients received somapacitan. Height velocity (HV; cm/year) at Weeks 52 and 104 were
Somapacitan in Children Born SGA: 52-week Efficacy, Safety, and IGF-I Response Results from the Phase 2 REAL5 Study. Somapacitan, a once-weekly reversible albumin-binding GH derivative, is evaluated in short children born small for gestational age (SGA). Evaluate efficacy, safety, tolerability as well as total and bioactive insulin-like growth factor-I (IGF-I) response of once-weekly somapacitan :1:1:1) to somapacitan (0.16, 0.20 or 0.24 mg/kg/week) or daily GH (0.035 or 0.067 mg/kg/day), all administered subcutaneously. Estimated mean height velocity (HV; cm/year) at week 52 was 8.5, 10.4 and 10.7 cm/year for somapacitan 0.16, 0.20 and 0.24 mg/kg/week, respectively, and 9.3 and 11.2 cm/year for daily GH 0.035 and 0.067 mg/kg/day, respectively. Dose-dependent increases in total IGF-I
Effective GH Replacement with Somapacitan in Children with GHD: REAL4 2-year Results and after Switch from Daily GH. Somapacitan is a long-acting GH derivative for treatment of GH deficiency (GHD). Evaluate the efficacy and tolerability of somapacitan in children with GHD after 2 years of treatment and after switch from daily GH. A randomised, multi-national, open-labelled, controlled parallel group phase 3 trial, comprising a 52-week main phase and 3-year safety extension (NCT03811535). Eighty-five sites across 20 countries. 200 treatment-naïve pre-pubertal patients were randomized and exposed. 194 completed the 2-year period. Patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) during the first year, after which all patients received somapacitan 0.16
Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety and Treatment/Disease Burden Results from REAL 3. GH deficiency (GHD) in children is currently treated with daily injections of GH, which can be burdensome for patients and their parents/guardians. Somapacitan is a GH-derivative in development for once-weekly treatment of GHD. Assess the efficacy and safety of somapacitan , and associated disease/treatment burden, after 4 years of treatment and 1 year after switching to somapacitan from daily GH. Long-term safety extension of a multicenter, controlled phase 2 trial (NCT02616562). Twenty-nine sites in 11 countries. Prepubertal, GH-naïve children with GHD. Fifty patients completed 4 years of treatment. Patients in the pooled group received somapacitan (0.04, 0.08, 0.16 mg/kg/week
Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. The long-term effects of long-acting growth hormone (LAGH) analogues on glucose metabolism in adult growth hormone deficiency (AGHD) are not known. We investigated the impact of LAGH somapacitan, administered once-weekly, on glucose metabolism in patients with AGHD. In post hoc-defined analyses, we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-β) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan). No new cases
Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study. Investigate efficacy, safety, and tolerability of 3 once-weekly somapacitan doses compared with daily growth hormone (GH) administration in short children born small for gestational age (SGA). Randomised, multi-centre, open-label, controlled phase 2 study comprising a 26-week main phase and a 4-year extension (NCT03878446). The study was conducted at 38 sites across 12 countries. 26-week main phase results are presented here.Sixty-two GH treatment-naïve, prepubertal short children born SGA were randomised and exposed; 61 completed the main phase. Three somapacitan doses (0.16 [n = 12], 0.20 [n = 13], 0.24 [n = 12] mg/kg/week) and 2 daily GH doses (0.035 [n = 12], 0.067 [n = 13] mg/kg
Gene expression signatures predict first-year response to somapacitan treatment in children with GH deficiency. The pre-treatment blood transcriptome predicts growth response to daily GH therapy with high accuracy. Investigate response prediction using pre-treatment transcriptome in children with GH deficiency (GHD) treated with once-weekly somapacitan, a novel long-acting GH. REAL4 is a randomised, multinational, open-labelled, active-controlled parallel group phase 3 trial, comprising a 52-week main phase and an ongoing 3-year safety extension (NCT03811535). 128/200 treatment-naïve prepubertal children with GHD consented to baseline blood transcriptome profiling. Randomized 2:1 to subcutaneous somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day). Differential RNA-seq analysis
Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3. Current GH therapy requires daily injections, which can be burdensome. Somapacitan is a long-acting GH derivative in development for treatment of GH deficiency (GHD). Evaluate the efficacy, safety, and tolerability of once-weekly somapacitan after 3 years of treatment . A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562). Twenty-nine sites in 11 countries. Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment. Fifty-three children completed the 3-year period. Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d
Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency. Growth hormone (GH) replacement therapy in patients with adult growth hormone deficiency (AGHD) is individually titrated due to variable dose-responses among patients. The aim of this study was to provide clinical guidance on dosing and titration of the novel long-acting GH derivative somapacitan based on analyses of somapacitan dose-insulin-like growth factor I (IGF-I) responses in AGHD patients. Analyses of dosing information, 4364 somapacitan concentration samples and 4880 IGF-I samples from 330 AGHD patients treated with somapacitan in three phase 3 trials. Pharmacokinetic/pharmacodynamic modelling was used to evaluate starting dose groups by age and oral oestrogen therapy, characterise the dose-IGF-I
Weekly Somapacitan is Effective and Well Tolerated in Children with GH Deficiency: The Randomized Phase 3 REAL4 Trial. Somapacitan, a once-weekly reversible albumin-binding GH derivative, is evaluated in children with GH deficiency (GHD). To demonstrate efficacy and safety of somapacitan versus daily GH. REAL4 is a randomised, multi-national, open-labelled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and three-year extension (NCT03811535). Eighty-six sites across 20 countries. 200 treatment-naïve patients were randomized and exposed. Patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day), administered subcutaneously. The primary endpoint was annualized height velocity (HV; cm/year) at week 52
Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. Somapacitan is a long-acting growth hormone (GH) derivative being developed for once-weekly dosing in patients with GH deficiency (GHD). Our objective was to evaluate the impact of kidney or hepatic impairment on somapacitan exposure in adults. In two open somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15. Blood samples were collected before each dose, at 28 time points throughout 2 weeks after the last dose, and at follow-up (3-4 weeks after the last dose). The primary endpoint was area under the somapacitan serum concentration-time curve up to 1 week after the last dose (AUC), while secondary endpoints included AUC of insulin-like growth factor
Somapacitan An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM Levels and EffectsSummary of Use during LactationBecause somapacitan is a large molecule that is poorly absorbed orally, it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. However, there is no published experience with somapacitan during breastfeeding, so an alternate drug may be preferred, especially while nursing a newborn or preterm infant.Drug