Developments in the Management of Growth Hormone Deficiency: Clinical Utility of Somapacitan

Abstract

Growth hormone (GH) replacement therapy for growth hormone deficiency (GHD) in children and adults has for over 25 years, until recently, been administered as daily injections. This daily treatment regimen often incurs a burden to patients and caregivers, leading to high rates of non-adherence and, consequently, decreased treatment efficacy outcomes. To address this shortcoming, long-acting growth hormones (LAGHs) have been developed with the aim of reducing the burden of daily injections, thereby potentially improving treatment adherence and outcomes. Somapacitan (Sogroya^®) (Novo Nordisk, Bagsværd, Denmark) is a LAGH currently approved for the treatment of adult and childhood GHD (AGHD and CGHD, respectively) in several countries. Other LAGHs, such as somatrogon (Ngenla^®) (Pfizer, New York, United States) and lonapegsomatropin/TransCon GH (Skytrofa^®) (Ascendis Pharma, Copenhagen, Denmark), are also currently approved and available for the treatment of CGHD in several countries. In this review, we will consider the method of protraction, pharmacokinetics (PK) and pharmacodynamics (PD), efficacy, and safety results of somapacitan in adult and pediatric trials and how these characteristics differ from those of the other aforementioned LAGHs. Additionally, the administration of somapacitan and timing of measurement of serum insulin-like growth factor-I (IGF-I) levels are summarized. Information on administration, advice on missed doses, and clinical guidelines are discussed, as well as identifying which patients are suitable for somapacitan therapy, and how to monitor and adjust dosing whilst on therapy.

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Keywords:

• (3–6): growth hormone
• long-acting growth hormone
• adult growth hormone deficiency
• pediatric growth hormone deficiency
• adherence

Abbreviations

AGHD, adult growth hormone deficiency; AE, adverse event; AUC, area under the curve; CTP, carboxy-terminal; CGHD, childhood growth hormone deficiency; CI, confidence interval; ER, estimated ratio; EMA European Medicines Agency; ETD, estimated treatment difference; FDA, Food and Drug Administration; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; GH, growth hormone; GHD growth hormone deficiency; [³H]-somapacitan, tritium-labelled somapacitan; HV, height velocity; HOMA-β, homeostasis model assessment of beta-cell function; HOMA-IR, homeostasis model assessment of insulin resistance; IGFBP-2, insulin-like growth factor binding protein-2; IGFBP-3, insulin-like growth factor binding protein-3; IGF-I, insulin-like growth factor-I; LAGH, long-acting growth hormone; PD, pharmacodynamics; PK, pharmacokinetics; P-STAT5, phosphorylated STAT5; SD, standard deviationSDS, standard deviation score; TSQM-9, Treatment Satisfaction Questionnaire for Medication-9.

Data Sharing Statement

The data for this review article were publicly sourced from the literature.

Acknowledgments

The authors thank Novo Nordisk Health Care AG for reviewing the article for medical accuracy. Editorial support (in the form of writing assistance, collating author comments, assembling tables/figures, grammatical editing, and referencing) was provided by Emra Baker, Izabel James, and Helen Marshall of Ashfield Medcomms, and was funded by Novo Nordisk Health Care AG.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; agreed on the journal to which the article was submitted; and agree to be accountable for all aspects of the work.

Disclosure

B.S.M.: Consulted for Ascendis Pharma, BioMarin, Bristol Myers Squibb, EMD Serono, Endo Pharmaceuticals, Eton Pharmaceuticals, GenSci, Novo Nordisk, Orchard Therapeutics, Pfizer, Provention Bio, and Tolmar; and received research support from Alexion, AbbVie, Ascendis Pharma, Aeterna Zentaris, Amgen, Amicus, Foresee Pharmaceuticals, Lumos Pharma, Lysogene, Novo Nordisk, OPKO Health, Pfizer, Prevail Therapeutics, and Sangamo Therapeutics. J.B.: Received honoraria for presentations at meetings sponsored by Novo Nordisk, Sandoz, and Ipsen; received sponsorship to attend scientific meetings from Novo Nordisk; and received payment for membership of the Publication Steering Committee of the International Outcomes Study, sponsored by Novo Nordisk. R.H: Advisory board member and lecturer for Novo Nordisk, Pfizer, Lumos Pharma, JCR, and Sandoz. A.L.: Consulted for/received research funding/honoraria from Novo Nordisk, Merck Serono, Alexion, AstraZeneca Rare Disease, and Pfizer Inc; and received honoraria from Ipsen and Sandoz. K.C.J.Y.: Received research grants to Barrow Neurological Institute from Crinetics, Ascendis, Corcept, Amryt, and Sparrow; served as an occasional advisory board member for Novo Nordisk, Ascendis, Ipsen, Amryt, Crinetics, Recordati, Neurocrine, and Xeris; lecture fees from Pfizer; and served as occasional speaker for Recordati and Novo Nordisk.

Additional information

Funding

Writing support for this review article was funded by Novo Nordisk Health Care AG.