Canada launches Sogroya: a pioneering once-weekly growth hormone treatment
Canada has officially announced the commercialization of Sogroya® (somapacitan injection), marking a significant advancement in the treatment of growth hormone deficiency (GHD). As the first-and-only once-weekly growth hormone (GH) therapy indicated for both pediatric and adult patients, Sogroya® offers a convenient alternative to daily injections for people living with GHD. The drug was approved by Health Canada on July 26, 2023, and is now available across the country through Novo Nordisk Canada.
What is Sogroya® and who can benefit?
Sogroya® is a prescription human growth hormone analog designed to replace deficient endogenous GH in children and adults with GHD. For pediatric patients, Sogroya® supports long-term growth in those with growth failure due to inadequate GH secretion. In adults with GHD (AGHD), it targets body composition, energy levels, and metabolic health by providing a steady GH replacement. The once-weekly dosing aims to simplify treatment regimens, potentially improving adherence and daily quality of life for patients and families, especially in pediatric care.
Why a weekly treatment matters
Many patients, caregivers and clinicians emphasize that reducing the frequency of injections can ease the daily burden of GH therapy. By delivering a full week’s dose at once, Sogroya® may help minimize treatment disruption, support routine adherence, and improve overall treatment satisfaction without compromising efficacy when compared with daily GH regimens.
Clinical evidence and real-world impact
Health Canada’s approval for pediatric use is supported by the REAL 4 phase 3 study, which enrolled 200 treatment-naïve children aged 2.5 to 11 years with GHD. Participants received either once-weekly Sogroya® (132) or daily somatropin (68) for 52 weeks. The study demonstrated non-inferiority of weekly Sogroya® to daily somatropin in annualized height velocity, with a small estimated difference that fell within acceptable confidence intervals. The most common side effects included headaches, injection-site reactions, and metabolic changes, consistent with other GH therapies.
In adults with AGHD, the REAL 1 trial compared Sogroya® to daily GH and placebo. The results showed a significant reduction in truncal fat and improvements in lean body mass and IGF-I SDS, suggesting meaningful benefits in body composition. Importantly, Sogroya® was generally well tolerated, with adverse events similar to those observed with daily GH therapy. These data collectively support Sogroya® as a viable long-term treatment option for both pediatric and adult patients with GHD.
Safety, monitoring and patient support
As with other GH therapies, ongoing monitoring by healthcare professionals is essential. Potential adverse events noted in clinical studies include injection-site reactions, metabolic changes and hypothyroidism, underscoring the need for regular follow-up visits to adjust dosing and monitor growth, metabolism and overall health. Patients and caregivers should review the product labeling and safety information with their clinician to understand benefits and risks in the context of individual health profiles.
What this means for the Canadian GHD community
The introduction of Sogroya® in Canada represents a meaningful step in advancing patient-centered care for GHD. By offering a once-weekly option, clinicians can tailor treatment plans that align with families’ routines and patients’ lives, potentially supporting long-term adherence and improved outcomes. Novo Nordisk Canada emphasizes the company’s commitment to making medication delivery simpler and more convenient, an important consideration for both pediatric patients and adults navigating daily living with GHD.
About Sogroya® and access
Sogroya® (somapacitan injection) is a prescription GH analog indicated for long-term treatment of pediatric patients with growth failure due to GHD and for GH replacement in adults with AGHD. The product continues to be part of Novo Nordisk’s broader effort to advance growth hormone deficiency care, with consumer information and safety data available at novonordisk.ca. Health care providers and patients should consult the product monograph for detailed information and guidance.
About GHD and ongoing care
Growth hormone deficiency is a rare condition that can impact growth, body composition, cardiovascular and metabolic health. Early diagnosis and effective hormone replacement therapy remain critical components of management, with options like Sogroya® expanding the toolkit for clinicians and families.
About Novo Nordisk
Novo Nordisk is a global healthcare company focused on diabetes care and other serious chronic diseases. The company emphasizes science-driven innovation and patient access, with a workforce spanning dozens of countries and products available in many markets, including Canada.
