Sogrua (somapsitan) Receives Approval in Japan as the First Long-acting Growth Hormone for Low Stature in SGA Syndrome and Noonan Syndrome – Novo Nordisk

Novo Nordisk Pharma Co., Ltd. (Japan) announced an adaptation to the existing approval for its long-acting human growth hormone analog formulation “Sogrua”  (generic name: Somapsitan (genetically modified)). The newly identified “SGA short stature without epiphyseal closure” and “short stature in Noonan syndrome without epiphyseal closure” are now included as paediatric indications.

Until now, Sogrúya  has been used to treat conditions such as growth hormone deficiency short stature (GHD), but with the addition of two new pediatric indications, it will expand the possibility of offering a new treatment option of once-weekly dosing to more patients. Clinical trials have demonstrated efficacy and safety equivalent to existing once-daily formulations, and in SGA-related short stature, superiority has been shown compared to the low-dose group.

SGA short stature is a condition where the body is small relative to gestational age and cannot keep up with subsequent growth. Additionally, Noonan syndrome is known to develop due to genetic factors and is associated with short stature as well as various complications such as heart disease.

While continuation of growth hormone therapy is considered important in the treatment of short stature, daily injections place a heavy burden on patients and their families, posing challenges in reducing adherence to treatment. Sogrúya is characterized by being administered once a week, and by significantly reducing the number of injections, it is expected to continue treatment and improve quality of life.

Martin Jihima, Director and Head of Development at Novo Nordisk Pharma Co., Ltd., stated: “We are pleased to announce that Soglouja has received a new indication for SGA short stature and short stature in Noonan syndrome. This approval marks an important step toward fulfilling our mission to transform rare diseases. By adding the option of once-weekly dosing, it is expected to reduce the burden on patients from daily injections and lead to continued treatment. We will continue to contribute to improving the quality of life for children with growth disabilities and their families.”

This expansion is based on a clinical trial program (REAL) that includes 216 children with SGA low stature and 90 children with Noonan syndrome. Throughout the REAL program, Soglourya showed results equivalent to the primary endpoint—growth rate—comparable to the existing once-daily growth hormone ^{formulation Norditropin} (Novo Nordisk’s hGH formulation), and no new safety concerns were identified. Furthermore, SGA shortness showed superiority compared to the low-dose group.