Novo Nordisk's Sogroya approved by FDA for three new pediatric indications

Investing.com – Novo Nordisk announced on Friday evening that the U.S. Food and Drug Administration has approved three new indications for weekly injectable Sogroya (somapacitan-beco) 5 mg, 10 mg, or 15 mg, a long-acting growth hormone.

Sogroya is now approved for children aged 2.5 years and older with idiopathic short stature, those born small for gestational age who have not caught up in growth by age 2, or with growth failure related to Noonan syndrome. Sogroya is also indicated for growth hormone deficiency in children aged 2.5 years and older, as well as adults.

Nicky Kelepouris, U.S. Medical Director for Rare Endocrine Diseases, said: “For over 40 years, daily injections have been the paradigm for treating growth disorders. Our leadership in science and focus on advancing care for rare diseases prompted us to develop Sogroya—a once-weekly growth hormone therapy—that may help address the challenges of daily injections while providing an effective and safe treatment option for patients and families. These new approvals expand the patient populations who can benefit from Sogroya, reflecting our strategic focus on providing meaningful, evidence-based innovations for children with growth disorders.”

For children and their caregivers, daily injections of growth hormone 365 times a year can be a common challenge. The once-weekly option offers 313 days each year without injections.

Dr. Aristides Maniatis, founder of Rocky Mountain Pediatric Endocrinology Center in Centennial, Colorado, and investigator in the trial, said: “Families and healthcare professionals can now choose once-weekly growth hormone as a treatment option, providing 313 days each year without injections for children aged 2.5 years and older with idiopathic short stature, Noonan syndrome, and those born small for gestational age. Sogroya is an effective alternative to daily injections, supporting children’s growth goals and potentially helping them integrate into their daily lives.”

These approved REAL8 pivotal studies included three sub-studies, all of which met their primary endpoints. The studies showed that in children aged 2.5 years and older with the three indications, weekly Sogroya was non-inferior to daily growth hormone treatment in terms of mean annualized height velocity at week 52.

In children with idiopathic short stature, Sogroya demonstrated non-inferiority in mean annualized height velocity, at 10.2 cm/year compared to 10.5 cm/year with daily somatropin. The daily somatropin dose was 0.05 mg/kg/day, below the maximum approved pediatric dose of 0.067 mg/kg/day in the U.S.

In children born small for gestational age who had not caught up in growth by age 2, Sogroya was non-inferior to daily growth hormone at doses of 0.035 mg/kg/day and 0.067 mg/kg/day, with mean annualized height velocities of 11.0 cm/year, 9.4 cm/year, and 11.1 cm/year, respectively. The 0.035 mg/kg/day dose was below the U.S. maximum approved dose.

In children with growth failure related to Noonan syndrome, Sogroya was non-inferior to daily somatropin, with mean annualized height velocities of 10.4 cm/year versus 9.2 cm/year. The daily somatropin dose used was 0.050 mg/kg/day, below the maximum approved dose of 0.066 mg/kg/day.

In the REAL8 study, at least 10% of patients treated with Sogroya across all three indications experienced adverse reactions such as respiratory infections, nasopharyngitis, ear infections, and diarrhea. Other reactions occurring in at least 10% of Sogroya-treated patients included headache in children with idiopathic short stature and Noonan syndrome, as well as cough, fever, and vomiting in children with Noonan syndrome and small for gestational age, and injection site reactions in children with idiopathic short stature.

Novo Nordisk has also submitted a supplemental application for Sogroya for the treatment of Turner syndrome in the U.S., with a decision expected later this year.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.