FDA Approves Somapacitan as Once Weekly Injection for 3 Pediatric Indications

The FDA approved 3 new pediatric indications for Sogroya (somapacitan-beco), marking it as the first once-weekly, long-acting growth hormone. This regulatory milestone expands the use of the human growth hormone analogue to include children 2.5 years and older with idiopathic short stature (ISS), those born small for gestational age (SGA) with no catch-up growth by age 2 years, and those with growth failure associated with Noonan syndrome (NS).¹

These new indications add to somapacitan-beco’s existing approvals for pediatric and adult growth hormone deficiency (GHD), giving it the broadest range of approved indications among long-acting growth hormones currently on the market.¹

For pharmacists and clinical providers, this approval offers a significant alternative to the traditional treatment paradigm of daily injections that has defined the space for over 4 decades. By utilizing a once weekly dosing schedule, somapacitan-beco may directly address the common challenge of treatment nonadherence associated with daily therapy. The pharmacological foundation of this weekly schedule lies in the drug's ability to reversibly bind to endogenous albumin, a mechanism that delays its elimination and significantly prolongs its half-life and duration of action.^1,2

The FDA's decision was supported by data from REAL8 (NCT05330325), a pivotal multicenter, randomized, phase 3 study conducted in pediatric patients who were growth hormone treatment-naïve. Across all 3 new indications, the once weekly injection demonstrated noninferiority to once daily somatropin regarding the primary end point of mean annualized height velocity at week 52. Specifically, children with SGA treated with somapacitan-beco showed a mean annualized height velocity of 11.0 cm/year, and those with NS and ISS showed 10.4 cm/year and 10.2 cm/year, respectively.^1-3

Pharmacists should be aware of the specific dosing and administration requirements for these new indications. For pediatric patients with SGA, NS, or ISS, the recommended starting dosage is 0.24 mg/kg of body weight administered subcutaneously once weekly. This differs from the 0.16 mg/kg starting dose used for pediatric growth hormone deficiency. When patients are switching from a daily growth hormone to somapacitan-beco, they should be advised to choose a preferred day for their weekly dose and ensure their final daily injection is taken at least 8 hours before the first somapacitan-beco dose.²

Inventory management and storage counseling are also critical, as the medication is available in 3 single-patient-use prefilled pens: 5 mg, 10 mg, and 15 mg. Unopened pens must be stored in a refrigerator between 2°C and 8°C (36°F to 46°F) until the expiration date. Once a pen is in use, it can be stored in the refrigerator for up to 6 weeks. Pharmacists must emphasize to caregivers that the total time the pen is kept at room temperature (up to 25°C or 77°F) must not exceed 72 hours, regardless of whether the pen has been opened.^2,4

Clinical monitoring remains a priority, as somapacitan-beco is contraindicated in patients with active malignancy, acute critical illness, or pediatric patients with closed epiphyses. Pharmacists should screen for potential drug interactions, particularly with glucocorticoids, oral estrogens, and insulin, as the initiation of growth hormone therapy may necessitate dosage adjustments for these treatments.^1,2

Although the most common adverse reactions in children include respiratory tract infections, nasopharyngitis, and headaches, providers should also monitor for rare but serious risks such as intracranial hypertension, slipped capital femoral epiphysis, and new-onset hyperglycemia. If a dose is missed, it can be administered within 72 hours of the scheduled day; however, if more than 3 days have elapsed, the dose should be skipped entirely to resume the regular schedule on the next planned day.^1,2,4

REFERENCES

1. FDA approves Novo Nordisk’s Sogroya as the first and only once weekly, long-acting growth hormone for 3 additional pediatric indications. News release. Novo Nordisk. February 27, 2026. Accessed March 2, 2026. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916507

2. Sogroya (package insert). Novo Nordisk; 2026. Accessed March 2, 2026. https://www.novo-pi.com/sogroya.pdf

3. A research study to compare somapactian once a week with Norditropin Once a day in children who need help to grow (REAL 8). ClinicalTrials.gov identification: NCT05330325. Updated February 12, 2026. Accessed March 2, 2026. https://clinicaltrials.gov/study/NCT05330325

4. Mayo Clinic. Somapacitan-beco (subcutaneous route). Updated February 1, 2026. Accessed March 2, 2026. https://www.mayoclinic.org/drugs-supplements/somapacitan-beco-subcutaneous-route/description/drg-20502446