Investing.com — announced late Friday that the US Food and Drug Administration has approved three new indications for once-weekly Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone.
Sogroya is now indicated for children aged 2.5 years and older with Idiopathic Short Stature, short stature born Small for Gestational Age with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome. Sogroya is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency.
Nicky Kelepouris, Rare Endocrine Disorders-US Medical Lead, said: “Daily injections have defined the growth disorder treatment paradigm for more than 40 years. Our scientific leadership and focus on advancing care in rare diseases led us to the development of Sogroya – a once weekly growth hormone therapy – which may help address the challenge of daily injections while offering patients and families a therapeutic option that delivers efficacy and safety. These new approvals expand the patient populations that can be helped by Sogroya and reflect our strategic focus on delivering meaningful, evidence-based innovation for children living with growth disorders.”
Compliance to 365 daily injections per year for growth hormone treatment can be a common challenge for children and their caregivers. The once-weekly option provides 313 injection-free days per year.
Dr. Aristides Maniatis, Founder of Rocky Mountain Pediatric Endocrinology in Centennial, Colorado, and an investigator in the trial, said: “Families and healthcare professionals now have the option to consider a once-weekly growth hormone as treatment with 313 injection free days per year for their children 2.5 years and older with ISS, NS, and born SGA. Sogroya is an effective alternative to daily injections that supports children’s growth goals and may help fit into their routine.”
The REAL8 pivotal study for these approvals contained three sub studies that achieved their primary endpoint. The study demonstrated that once-weekly Sogroya was non-inferior to once-daily growth hormone treatment for mean annualized height velocity at Week 52 across the three indications in children aged 2.5 years and older.
In children with Idiopathic Short Stature, Sogroya demonstrated non-inferiority in mean annualized height velocity compared with daily somatropin at 10.2 versus 10.5 centimeters per year. The dose of 0.05 milligrams per kilogram per day of daily somatropin is less than maximum dose approved dose of 0.067 milligrams per kilogram per day for use in pediatric patients in the US.
In children born Small for Gestational Age with no catch up by 2 years of age, Sogroya demonstrated non-inferiority compared to both daily growth hormone doses of 0.035 milligrams per kilogram per day and 0.067 milligrams per kilogram per day with a mean annualized height velocity of 11.0 centimeters per year versus 9.4 centimeters per year versus 11.1 centimeters per year respectively. The daily growth hormone dose of 0.035 milligrams per kilogram per day is less than the maximum approved dose of 0.067 milligrams per kilogram per day in the US.
In children with growth failure associated with Noonan Syndrome, Sogroya demonstrated non-inferiority in mean annualized height velocity compared to daily somatropin at 10.4 versus 9.2 centimeters per year. The daily somatropin dose of 0.050 milligrams per kilogram per day used is less than the maximum approved dose of 0.066 milligrams per kilogram per day in the US.
In REAL8, the adverse reactions occurring in at least 10% of patients treated with Sogroya across all three indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in at least 10% of patients treated with Sogroya included headache in Idiopathic Short Stature and Noonan Syndrome, cough, pyrexia, and vomiting in Noonan Syndrome and Small for Gestational Age, and injection site reaction in Idiopathic Short Stature.
Novo Nordisk also submitted a supplemental application for Sogroya for approval in the US for Turner Syndrome. A decision is expected later this year.
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