Expert Q&A: Key Counseling Points for FDA-Approved Somapacitan in Growth Disorders

In an interview with Pharmacy Times, Nicky Kelepouris, MD, United States medical lead of rare endocrine disorders at Novo Nordisk, discussed the REAL8 (NCT05330325) trial and the expanded FDA pediatric indications for somapacitan-beco (Sogroya; Novo Nordisk), the first and only once-weekly, long-acting growth hormone approved for 3 additional pediatric growth disorders: short stature born small for gestational age (SGA), idiopathic short stature (ISS), and Noonan Syndrome (NS).

The REAL8 trial reported that the once-weekly formulation of somapacitan delivered similar clinical outcomes and a comparable safety profile to daily growth hormone across all three groups. Kelepouris emphasized that pharmacists are well-positioned to identify non-adherence, reinforce the safety and efficacy of once-weekly dosing, and serve as an accessible resource for families navigating the complexities of long-term pediatric growth hormone therapy.

Pharmacy Times: The REAL8 trial used a basket design to evaluate somapacitan across 3 distinct pediatric growth disorders simultaneously. Can you explain the rationale behind this approach and what it offers in terms of understanding the drug's efficacy across different patient populations?

Nicky Kelepouris, MD: By evaluating SGA, ISS, and NS under 1 protocol, the REAL8 basket design allowed Novo Nordisk to study somapacitan-beco’s performance across populations using the same endpoints and timelines. Studying these populations together provides a clear, side-by-side view of where efficacy is consistent and where responses differ, based entirely on standardized, directly comparable data. Treating non-growth hormone deficiency growth disorders requires personalized care, acknowledging patients' complex and evolving needs. For pediatric patients, once-weekly treatment options support this individualized approach. In the trial, Novo Nordisk reported that its first and only once-weekly, long-acting growth hormone, somapacitan-beco, delivered similar clinical outcomes and a comparable safety profile to daily growth hormone across all 3 groups.

Pharmacy Times: The study is currently in a 2-year safety extension phase. What key questions are you hoping this extension will answer regarding long-term safety, growth velocity sustainability, and final adult height outcomes?

Kelepouris: As the REAL8 program moves into its 2-year extension, we aim to build on the strong 52-week results by confirming the long-term safety of once-weekly somapacitan-beco, understanding whether the growth velocity gains observed in the core study are sustained long-term, and generating the longitudinal data needed to assess how continued weekly treatment may influence final adult height across the 3 conditions.

Pharmacy Times: For pharmacists counseling families about the transition from daily to weekly injections, what are the most important clinical and practical considerations they should discuss, particularly regarding the 72-hour window for missed doses?

Kelepouris: According to the label, if a person misses a dose of somapacitan-beco, 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, the person should skip the missed dose and take the next dose on the regularly scheduled dosing day. If there are any questions on the prescribing window, we encourage people to contact their physician.

Pharmacy Times: The safety profile of somapacitan was consistent with the known profile of growth hormone therapy, but injection site reactions (ISRs) occurred in 10% or more of ISS patients specifically. What might explain this difference across indications, and how should pharmacists counsel patients to manage or minimize these reactions?

Kelepouris: Adverse events can stem from various study population factors; importantly, ISS does not inherently increase susceptibility to ISRs. As with any injectable therapy, some degree of injection site reaction may be expected, since introducing a medication under the skin may cause temporary redness, itching, or discomfort in some patients, and it is also dependent on injection technique. Of note is that injection site reactions also occurred with daily somatropin (Norditropin; Novo Nordisk), further supporting that this may occur with any type of subcutaneous injection. The label does indicate that injection sites should be rotated on a regular basis, and with somapacitan-beco, it is able to be injected into the upper arms, thigh, abdomen, or buttocks.

Pharmacy Times: Growth hormone therapy requires coordination between multiple health care providers. From your perspective, what is the pharmacist's most valuable contribution to the multidisciplinary care team managing pediatric patients on somapacitan?

Kelepouris: Pharmacists play a key role in helping families navigate long-term growth-hormone therapy, especially by identifying non-adherence, a common challenge with daily injections, while also reinforcing the safety and efficacy of once-weekly treatment. They can serve as an accessible source of practical guidance complementing the work of the broader care team.

Pharmacy Times: Is there anything else that you would like to add, or anything that I missed?

Kelepouris: As the first and only once-weekly, long-acting growth hormone for these 3 additional pediatric indications, somapacitan-beco may help address the challenges of daily injections while offering patients and families a therapeutic option that delivers similar efficacy and safety. Somapacitan-beco is an effective alternative to daily injections that supports children's growth goals and may help fit into their daily routines.