FDA Approves Novo Nordisk's Sogroya as the First and Only Once-Weekly, Long-Acting Growth Hormone for Three Additional Pediatric Indications

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PLAINSBORO, N.J., Feb. 27, 2026 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone.1 Sogroya is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS).1 Sogroya is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD).1

  • New indications expand treatment options for appropriate children aged 2.5 years and older with Idiopathic Short Stature (ISS), born Small for Gestational Age (SGA), or Noonan Syndrome (NS)1
  • Sogroya (somapacitan-beco) is a once-weekly treatment option, offering an alternative to once-daily therapy, which may help address the common challenge of non-adherence associated with daily injections2
  • These FDA approvals build on decades of treatment innovation for growth disorders from Novo Nordisk
  • Sogroya now has the broadest range of approved indications among long-acting growth hormones

    • "Daily injections have defined the growth disorder treatment paradigm for more than 40 years. Our scientific leadership and focus on advancing care in rare diseases led us to the development of Sogroya – a once‑weekly growth hormone therapy – which may help address the challenge of daily injections while offering patients and families a therapeutic option that delivers efficacy and safety," said Nicky Kelepouris, Rare Endocrine Disorders-US Medical Lead. "These new approvals expand the patient populations that can be helped by Sogroya and reflect our strategic focus on delivering meaningful, evidence‑based innovation for children living with growth disorders."

    Compliance to 365 daily injections per year for growth hormone treatment can be a common challenge for children and their caregivers. Having an alternative once-weekly option may assist with this challenge.2,3,4

    "Families and healthcare professionals now have the option to consider a once-weekly growth hormone as treatment with 313 injection free days per year for their children 2.5 years and older with ISS, NS, and born SGA," said Dr. Aristides Maniatis, Founder, Rocky Mountain Pediatric Endocrinology (Centennial, CO) and an investigator in the trial. "Sogroya is an effective alternative to daily injections that supports children's growth goals and may help fit into their routine."

    REAL8, the pivotal study for these approvals, contained three sub studies that achieved their primary endpoint, demonstrating that once-weekly Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg was non-inferior to once-daily growth hormone treatment for mean annualized height velocity (AHV) at Week 52 across these three indications in children aged 2.5 years and older:

  • In children with ISS, Sogroya demonstrated non-inferiority in mean AHV compared with daily somatropin (10.2 vs 10.5 cm/year).1 The dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose approved dose (0.067 mg/kg/day) for use in pediatric patients in the US.1
  • In children born SGA with no catch up by 2 years of age, Sogroya demonstrated non-inferiority compared to both daily growth hormone doses (0.035 mg/kg/day and 0.067 mg/kg/day) with a mean AHV of 11.0 cm/year vs 9.4 cm/year vs 11.1 cm year respectively; daily growth hormone dose of 0.035 mg/kg/day is less than the maximum approved dose (0.067 mg/kg/day) in the US.1
  • In children with growth failure associated with NS, Sogroya demonstrated non-inferiority in mean AHV compared to daily somatropin (10.4 vs 9.2 cm/year); the daily somatropin dose of 0.050 mg/kg/day used is less than the maximum approved dose (0.066 mg/kg/day) in the US.1

    • In REAL8, the adverse reactions occurring in ≥10% of patients treated with Sogroya across all three indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in ≥10% of patients treated with Sogroya included: headache in ISS and NS; cough, pyrexia, and vomiting in NS and SGA; and injection site reaction in ISS.1

    Please see below for important safety information and please click here for the full Prescribing Information.

    Novo Nordisk also submitted a supplemental application for Sogroya for approval in the US for Turner Syndrome. A decision is expected later this year.

    About REAL8 The REAL8 study is part of the ongoing REAL clinical trial program. It is a multi-center, randomized, open-label, active-comparator, phase 3 basket study conducted in growth hormone treatment-naïve, pre-pubertal pediatric patients with short stature born Small for Gestational Age (SGA), Noonan Syndrome (NS), or Idiopathic Short Stature (ISS). The primary treatment period was 52 weeks, and the study is currently in a two-year safety extension phase.1 This is the first time a trial design of this type has been implemented in the growth disorder space.

    In the study, 142 pediatric patients aged 2.6 to 10.7 years with SGA were randomized to Sogroya 0.24 mg/kg/week (n=70), once-daily somatropin 0.035 mg/kg/day (n=37), or once-daily somatropin 0.067 mg/kg/day (n=35). Dose of 0.035 mg/kg/day of daily somatropin is less than maximum dose (0.067 mg/kg/day) approved for use in pediatric patients with SGA in the US.1

    Seventy-seven pediatric patients aged 2 to 11.1 years with NS were randomized to Sogroya 0.24 mg/kg/week (n=49) or once-daily somatropin 0.05 mg/kg/day (n=28). Dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose (0.066 mg/kg/day) approved for use in pediatric patients with NS in the US.1

    Eighty-eight pediatric patients aged 2.8 to 10.8 years with ISS were randomized to 0.24 mg/kg/day (n=60) or once-daily somatropin 0.05 mg/kg/day (n=28). Dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose (0.067 mg/kg/day) approved for use in pediatric patients with ISS in the US.1

    About once-weekly SogroyaOnce-weekly Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is a prescription human growth hormone analogue.5 On February 27, 2026, once-weekly Sogroya was approved in the US for children aged 2.5 years of age and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya was previously approved in the US for the replacement of endogenous growth hormone in adults with growth hormone deficiency (August 28, 2020) and for pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (April 28, 2023).

    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. Sogroya is given by injection under the skin (subcutaneous).
  • Sogroya is used to treat children 2.5 years of age and older who:
  • are not growing because of low or no growth hormone
  • are short (in stature) and were born small (Small for Gestational Age-SGA) and have not caught up in growth by age 2 years
  • are not growing and have Noonan Syndrome (NS)
  • have Idiopathic Short Stature (ISS)
  • Sogroya is used to treat adults who do not make enough growth hormone

    • Important Safety InformationDo 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:

  • have had heart or stomach surgery, trauma, or serious breathing problems
  • are taking replacement therapy with glucocorticoids
  • have had cancer or any tumor
  • have thyroid glad problems
  • have diabetes
  • have liver problems
  • have adrenal gland problems
  • are a child with a history of worsening of curvature of the spine (scoliosis)
  • 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. Your 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 (hyperglycemia) or diabetes. You or your child's blood sugar may need to be monitored during treatment with Sogroya
  • increase in pressure in the skull (intercranial hypertension). 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). This may lead to a serious condition where bone tissue dies due to lack of blood supply (osteonecrosis). Get medical help right away if your child develops a limp or has hip or knee pain
  • 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: cough, common cold, diarrhea, ear infection, headache, fever, pain in extremity, reaction to injection, respiratory tract infection, and vomiting

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

    About Novo NordiskNovo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 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, 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 a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs approximately 10,000 people throughout the country across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

    References

  • Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
  • 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.
  • Loftus J, Miller BS, Parzynski CS, et al. Association of daily growth hormone injection adherence and height among children with growth hormone deficiency. Endocr Pract. 2022;28:565-571.
  • Brod M, Hojbjerre L, Alolga SL, et al. Understanding treatment burden for children treated for growth hormone deficiency. Patient. 2017;10:653-666.
  • Johannson 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;59:1410-1419.

    • SOURCE Novo Nordisk

    Source: HealthDay

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    • Sogroya (somapacitan-beco) FDA Approval History

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    Posted : 2026-03-03 13:45

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