Novo Nordisk has announced that the US Food and Drug Administration (FDA) 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 (ISS), short stature born small for gestational age (SGA) and with no catch-up growth by two years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD).
“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,” said Nicky Kelepouris, rare endocrine disorders-US Medical Lead.
“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. Having an alternative once-weekly option may assist with this challenge.
“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,” said Dr. Aristides Maniatis, founder, Rocky Mountain Pediatric Endocrinology (Centennial, CO) and an investigator in the trial. “Sogroya is an effective alternative to daily injections that supports children’s growth goals and may help fit into their routine.”
REAL8, the pivotal study for these approvals, contained three sub studies that achieved their primary endpoint, demonstrating that once-weekly Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg was non-inferior to once-daily growth hormone treatment for mean annualized height velocity (AHV) at Week 52 across these three indications in children aged 2.5 years and older:
In children with ISS, Sogroya demonstrated non-inferiority in mean AHV compared with daily somatropin (10.2 vs 10.5 cm/year).1 The dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose approved dose (0.067 mg/kg/day) for use in pediatric patients in the US.
In children born with SGA with no catch up by 2 years of age, Sogroya demonstrated non-inferiority compared to both daily growth hormone doses (0.035 mg/kg/day and 0.067 mg/kg/day) with a mean AHV of 11.0 cm/year vs 9.4 cm/year vs 11.1 cm year respectively; daily growth hormone dose of 0.035 mg/kg/day is less than the maximum approved dose (0.067 mg/kg/day) in the US.
In children with growth failure associated with NS, Sogroya demonstrated non-inferiority in mean AHV compared to daily somatropin (10.4 vs 9.2 cm/year); the daily somatropin dose of 0.050 mg/kg/day used is less than the maximum approved dose (0.066 mg/kg/day) in the US.
In REAL8, the adverse reactions occurring in ≥10% of patients treated with Sogroya across all three indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in ≥10% of patients treated with Sogroya included: headache in ISS and NS; cough, pyrexia, and vomiting in NS and SGA; and injection site reaction in ISS.
Novo Nordisk also submitted a supplemental application for Sogroya for approval in the US for Turner Syndrome. A decision is expected later this year.
