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FDA Approves Once-Weekly Sogroya for the Treatment of Children Living with Growth Hormone Deficiency

PLAINSBORO, NJ, April 28, 2023 – Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya^® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.¹ With this new indication, Sogroya^® becomes the first and only once-weekly growth hormone (GH) treatment for both children and adults.¹

The FDA approval of the new indication for children with GHD is based on data from the phase 3 REAL4 study. In the study, two hundred treatment-naïve patients aged 2.5 – 11 years with GHD were either given once-weekly Sogroya^® (n=132) or daily somatropin (n=68) for 52 weeks.¹ The results showed that Sogroya^® was comparable to daily somatropin for the primary endpoint of annualized height velocity (11.2 cm/year vs. 11.7 cm/year, respectively).² Adverse reactions in the REAL4 study occurring in more than 5% of patients included nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reactions.¹

Children with GHD typically experience short stature and can also have an increased risk for other growth-associated problems.³ For decades, GH replacement has been the standard of care to improve growth outcomes.^4,5 Patients may struggle with a daily injection routine over the long term, and according to the Growth Hormone Research Society consensus, a once-weekly GH option offers patients and families a therapeutic alternative.^6,7

“At Novo Nordisk, we continue to build on our 25-year heritage and expertise in rare endocrine disorders, including growth hormone deficiency, to deliver a broad range of products and services to the community. A once-weekly growth hormone treatment like Sogroya^® may offer a therapeutic alternative for patients and their caregivers interested in a once-weekly option,” said Stephanie Seremetis, MD, CMO and CVP, Rare Disease, Novo Nordisk.

Sogroya^® leverages albumin-binding technology developed by Novo Nordisk for other disease areas.^1,8 It binds to endogenous albumin, which delays elimination of somapacitan-beco and thereby prolongs the in vivo half-life and duration of action.¹

The Sogroya^® pen is based on the FlexPro^® pen, which has more than 10 years of patient experience.⁹ Sogroya^® will be provided in a prefilled, premixed, portable pen that is stable at room temperature (up to 77^oF) for up to a maximum of 72 hours.¹

Novo Nordisk plans to make Sogroya^® available for both pediatric and adult patients in the coming months.

What is Sogroya^® ?

• Sogroya^® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body.
• It is given by injection under the skin (subcutaneous) and is used to treat adults and children 2.5 years and older who do not make enough growth hormone.

Important Safety Information

Do not use Sogroya^® if:

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
• you have cancer or other tumors
• you are allergic to somapacitan-beco or any of the ingredients in Sogroya ^®
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes
• you are a child with closed bone growth plates
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep)

Before taking Sogroya^®, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Sogroya ^® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if Sogroya ^® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya ^® while you breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya^® may affect the way some medicines work, and some medicines may affect how Sogroya^® works.

How should I use Sogroya^® ?

• Use Sogroya ^® exactly as your healthcare provider tells you to
• Use Sogroya^® 1 time each week
• If you miss a dose of Sogroya^®, the missed dose can be taken within 3 days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day
• If more than 3 days (72 hours) have passed, skip the missed dose, and take your next dose on the regularly scheduled dosing day
• Sogroya^® pens are for use by 1 person only
• Do not share your Sogroya^® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them

What are the possible side effects of Sogroya^® ?

Sogroya^® may cause serious side effects, including:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems
• increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. You or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin
• new or worsening high blood sugar or diabetes. You or your child’s blood sugar may need to be monitored during treatment with Sogroya^®
• increase in pressure in the skull. If you or your child have headaches, eye problems, nausea or vomiting, contact the healthcare provider
• serious allergic reactions. Get medical help right away if you or your child have the following symptoms: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating
• your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet. Tell your or your child’s healthcare provider if you or your child have any of these signs or symptoms of fluid retention
• decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child have darkening of the skin, severe fatigue, dizziness, weakness, or weight loss
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Sogroya ^® works. The healthcare provider will do blood tests to check you or your child’s thyroid hormone levels
• severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain
• loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject Sogroya^®
• worsening of curvature of the spine in children (scoliosis)
• hip and knee pain or a limp in children (slipped capital femoral epiphysis)
• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
• increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You or your child’s healthcare provider will do blood tests to check this

The most common side effects of Sogroya^® in children include: common cold, headache, fever, pain in extremity, and reaction to injection

The most common side effects of Sogroya^® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), vomiting, high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia)

Please see prescribing information at https://www.novo-pi.com/sogroya.pdf

About the REAL4 study
The REAL4 (REversible ALbumin) study (NCT03811535) is part of the ongoing REAL clinical study program and was designed to evaluate the efficacy and safety of Sogroya^® (somapacitan-beco) injection in children with growth hormone deficiency (GHD).² REAL4 is a randomized, open-label, active-controlled parallel-group phase 3 trial, comprised of a 52-week main phase followed by a three-year extension period.² Two hundred growth hormone (GH) treatment-naïve, prepubertal children with GHD were randomly assigned in a 2:1 ratio to receive weekly subcutaneous injection of 0.16 mg/kg/week Sogroya^® (n=132) or daily subcutaneous injection of 0.034 mg/kg/day somatropin (n=68).² The primary endpoint of REAL4 was annualized height velocity after 52 weeks of treatment.²

About growth hormone deficiency (GHD)
GHD is a rare disease estimated to affect approximately 1 in 3,500 to 10,000 children globally.^10,11 It is characterized by an insufficient amount of growth hormone (GH) circulating in the body.³ GH is essential for growth, muscle and bone strength, and GHD in children can result in slow growth from an early age, resulting in a shorter stature than expected for their age/sex.³

About Sogroya^®
Sogroya^® (somapacitan-beco) injection is a prescription human growth hormone (GH) analog. Sogroya^® was approved for the replacement of endogenous growth hormone in adults with growth hormone deficiency (AGHD) in the US on August 28, 2020.¹

About Novo Nordisk
Novo Nordisk is a leading global healthcare company that’s been making innovative medicines to help people with diabetes lead longer, healthier lives for 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in seven states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, and Twitter.

References

1. SOGROYA^® (somapacitan-beco) injection, for subcutaneous use [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2023.
2. Miller BS, Blair JC, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 2022;107(12):3378-3388. doi:10.1210/clinem/dgac513.
3. National Organization for Rare Disorders. Growth Hormone Deficiency. Accessed: April 2023. https://rarediseases.org/rare-diseases/growth-hormone-deficiency/
4. Greenhill, C. Once-weekly growth hormone. Nat Rev Endocrinol 13, 65 (2017). Accessed: April 2023. https://doi.org/10.1038/nrendo.2016.220
5. Höybye C, Christiansen JS. Growth hormone replacement in adults - current standards and new perspectives. Best Pract Res Clin Endocrinol Metab. 2015;29(1):115-123. doi:10.1016/j.beem.2014.09.006.
6. Brod M, Højbjerre L, Alolga SL, et al. Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient. 2017;10(5):653-666. doi:10.1007/s40271-017-0237-9.
7. Christiansen JS, Backeljauw PF, Bidlingmaier M, et al. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. Eur J Endocrinol. 2016 Jun;174(6):C1-8. doi: 10.1530/EJE-16-0111. Epub 2016 Mar 23.
8. Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59(14):1410-1419. doi:10.1021/acs.biochem.0c00019
9. Novo Nordisk. Data on File.
10. Stanley T. Diagnosis of growth hormone deficiency in childhood. Curr Opin Endocrinol Diabetes Obes. 2012;19(1):47-52. doi:10.1097/MED.0b013e32834ec952
11. Tornese G.’ Growth hormone deficiency’ or rather ‘short stature unresponsive to stimulation tests? Archives of Disease in Childhood Published Online First: 27 January 2022. doi: 10.1136/archdischild-2021-323426

Source: Novo Nordisk

Posted: April 2023

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