SOGROYA® AGHD

• ~6,000 new cases diagnosed annually⁶

• Adult-onset GHD is predominantly caused by pituitary tumours and their treatment (surgery and/or radiotherapy) and traumatic brain injury⁷

• Childhood-onset GHD often persists into adulthood⁷

Factors contributing to low diagnosis and treatment rates

• Symptoms are not always readily apparent⁸

• Symptoms may be attributed to other causes⁹

• Comorbidities complicate the clinical picture⁹

• Provocative testing is often non-specific and impractical^8,9

• Patients don’t fully appreciate the benefits of GH replacement¹⁰

• Cost can be high and patient access can be challenging^7,11

Based on an analysis of 3,350 adults with GHD treated by 187 endocrinologists in the US (childhood-onset n=992; adult-onset tumour-related n=1,440; adult-onset post-traumatic brain injury n=918)⁵

Adapted from Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial. J Clin Endocrinol Metab. 2020;105(4):1–19.

Adapted from Johannsson G, Feldt-Rasmussen U, Holme Håkonsson I, et al. Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. Eur J Endocrinol. 2018;178:491–499.

^a A 26-week, controlled Phase 3 trial of safety and tolerability conducted in 6 countries. A total of 92 AGHD patients aged 18–79 years who had been treated with oncedaily GH for ≥ 6 months were randomised to receive once-weekly Sogroya (n = 61) or once-daily GH (n = 31).³

Dose should be taken as soon as possible, and next dose should be taken on the regularly scheduled day.

Dose should be skipped, and next dose should be taken on the regularly scheduled day.

The day of weekly administration can be chosen by the patient.

Weekly dosing day can be changed, as long as the time between 2 doses is at least 4 days (96 hours).

Sogroya^® Summary of Product Characteristics.

Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial. J Clin Endocrinol Metab. 2020;105(4):1–19.

Johannsson G, Feldt-Rasmussen U, Håkonsson IH, et al. Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. Eur J Endocrinol. 2018;178(5):491–499.

Yuen KCJ, Llahana S, Miller BS. Adult growth hormone deficiency: clinical advances and approaches to improve adherence. Expert Rev Endocrinol Metab. 2019;14(6):419–436.

Data on file: Adivo Associates; Adult growth hormone deficiency market size USIDEICH. 2018.

Brod M, Pohlman B, Hojberre L, Adalsteinsson JE, Rasmussen MH. Impact of adult growth hormone deficiency on daily functioning and well-being. BMC Res Notes. 2014;7(813):1-9.

Molitch M, Clemmons D, Malozowski S, Merriam G, Vance ML. Evaluation and treatment of adult growth hormone deficiency: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587-1609.

Kargi A, Merriam G. Diagnosis and treatment of growth hormone deficiency in adults. Nat Rev Endocrinol. 2013;9:335-345.

Glynn N, Agha A. Diagnosing growth hormone deficiency in adults. Int J Endocrinol. 2012;2012:1-7.

10.

Svensson J, Bengsston BA, Rosén T, Oden A, Johannsson G. Malignant disease and cardiovascular morbidity in hypopituitary adults with or without growth hormone replacement therapy. J Clin Endocrinol Metab. 2004;89(7):3306-3312, doi:10.1210/jc.2003-031601.

11.

Rose S, Cook D, Fine M. Growth hormone therapy guidelines: clincial and managed care perspectives. Am J Pharm Benefits. 2014;6(5):e134-e146. https://www.ajpb.cm/journals/ajpb/2014/ajpb_spetemberoctober2014/growth-hormonetherapy- guidelines-clinical-and-managed-care-perspectives. Accessed November 27,2018.

12.

Fan Y, Menon RK, Cohen P, et al. Liver-specific deletion of the growth hormone receptor reveals essential role of growth hormone signaling in hepatic lipid metabolism. J Biol Chem. 2009;284(30):1-8.

13.

Koltowska-Häggström M, Mattsson A, Shalet S. Assessment of quality of life in adult patients with GH deficiency: KIMS contribution to clinical practice and pharmacoeconomic evaluations. Eur Soc Endocrinol. 2009;161:S51-S64. doi.org/10.1530/EJE-09-0266.

14.

Hakkart-van Roijen L, Beckers A, Stevenaert A, Rutten FF. The burden of illness of hypopituitary adults with growth hormone deficiency. Pharmacoeconomics. 1998;14(4):395-403.

15.

Ehrnborg C, Hakkart-van Roijen L, Jonsson B, Rutten FF, Bengtsson BA, Rosén T. Cost of illness in adult patients with hypopituitarism. Pharmacoeconomics. 2000;17(6):621-628.Ehrnborg C, Hakkart-van Roijen L, Jonsson B, Rutten FF, Bengtsson BA, Rosén T. Cost of illness in adult patients with

hypopituitarism. Pharmacoeconomics. 2000;17(6):621-628.

16.

Fleseriu M, Hashim I, Karavitaki N, et al. Hormonal replacement in hypopituitarism in adults: an endocrine society

clinical practice guideline. J Clin Endocrinol Metab. 2016;101(11):3888-3921. doi: 10.1210/jc.2016-2118.

17.

Cook D, Yuen K, Biller B, Kemp S, Vance ML. American association of clinical epidemiologists medical guidelines for clinical practice for growth hormone use in growth hormone-deficient adults and tansition patients-2009 update. Endocr Pract. 2009;15(suppl 2):1-29.

18.

Sogroya^® Package Leaflet.

19.

Rohrer TR, Horikawa R, Kappelgaard A-M. Growth hormone delivery devices: current features and potential for enhanced treatment adherence. Expert Opin Drug Deliv. 2017;14(11):1253–1264. doi:10.1080/1742547.2017.1243526.

Kappelgaard A-M, Mikkelsen S, Bagger C, Fuchs GS. Children and adolescent acceptability of a new device system to administer human growth hormone – a pilot study. J Pediatr Endocrinol Metab. 2012;25(3-4):285–294.

KS22SOM00013