Once-weekly growth hormone 'Sogroya' prescribed in gen hospitals

Has passed the drug committees of St. Mary’s Hospital, Severance Hospital, Asan Medical Center

Offering a long-acting treatment option…improved treatment adherence

Product photo of Sogroya

'Sogroya', a once-weekly growth hormone, is now available for prescription in general hospitals.

According to industry sources, Novo Nordisk Korea's long-acting growth hormone deficiency treatment Sogroya (somapacitan) has passed the drug committees (DC) of medical institutions, including Seoul National University Bundang Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital.

Sogroya was added to the health insurance reimbursement listing last May. Since then, the prescription area for this drug has expanded. Sogroya is reimbursed in pediatric patients with growth hormone deficiency who meet the following criteria ▲ height at or below the 3rd percentile for chronological age ▲ confirmed diagnosis through two or more growth hormone stimulation tests ▲ bone age delayed compared to chronological age.

Growth hormone deficiency can be accompanied by delayed growth rate and deficiencies in other pituitary hormones. Because patients must receive continuous treatment until the end of the growth period, treatment adherence significantly influences therapeutic outcomes.

The clinical efficacy and safety of Sogroya were confirmed through the global phase 3 REAL4 study.

The REAL4 study is a randomized, parallel-group, open-label, active-controlled phase 3 clinical trial evaluating the efficacy and safety of once-weekly Sogroya compared with once-daily growth hormone in 200 treatment-naïve, prepubertal pediatric patients with growth hormone deficiency.

The primary endpoint was annualized height velocity (HV; cm/y) at 52 weeks of treatment, with additional endpoints including change in height velocity SDS from baseline to 52 weeks, height SDS, bone age (BA) to chronological age (CA) ratio, and IGF-1 SDS.

In the REAL4 study, Sogroya demonstrated non-inferiority in annualized HV compared to daily growth hormone. At 52 weeks, annualized HV was similar across treatment groups, with 11.2 cm/year in the Sogroya group and 11.7 cm/year in the daily growth hormone group.

In terms of safety, the two treatment groups exhibited generally similar profiles, with most adverse events being mild or moderate; injection site reactions were reported in 5.3% and 5.9% of patients in the Sogroya and daily growth hormone groups, respectively.

Professor Young Suk Shim of the Department of Pediatrics at Ajou University Hospital stated, 'As growth hormone therapy continues over a long period, treatment adherence has a significant impact on treatment outcomes. Recently, the growth hormone treatment paradigm has been shifting from conventional daily injection therapy to long-acting growth hormone therapy that allows once-weekly administration.'