Novo’s Sogroya Impresses In Children With Convenience Advantage Over SOC
Executive Summary
The Danish firm’s injectable growth hormone analogue has succeeded in a late-stage study of children with a growth disorder and offers more convenient dosing that could improve adherence.
Novo Nordisk A/S’s Sogroya met the primary endpoint in an advanced trial in pediatric growth hormone deficiency, where its efficient dosing schedule could improve treatment adherence in the disease.
Once-weekly injection Sogroya (somapacitan) demonstrated non inferiority to Novo’s older somatopin product Norditropin, which is give once-daily, in the Phase III REAL 4 study in prepubertal children with growth hormone deficiency (GHD). Sogroya is already approved for GHD in adults in regions including the US and EU but label expansion to children is important because GHD symptoms start early in life and the condition affects around one in 3,500 to 10,000 children, compared with just one in 100,000 adults. (Also see "Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA" - Pink Sheet, 13 Sep, 2020.)
Novo is now aiming for a US filing in the prepubertal population in the second quarter of this year with a launch expected in 2023, head of R&D Martin Lange told Scrip. GHD is a rare disease that occurs when the anterior lobe of pituitary gland fails to produce enough growth hormone, which is essential for height growth, muscle and bone strength and controlling fat and sugar levels. The condition is more prevalent in males than females, although this could be due in part to sex-based referral and treatment biases, and is characterized by slow growth, short stature and other health problems.
The REAL-4 trial enrolled 200 growth hormone treatment-naive prepubertal children with GHD, around 75% of whom were male. Data revealed at the Endocrine Society’s Annual Meeting in Atlanta, GA showed Sogroya produced an annualised height velocity (AHV) of 11.2cm a year at 52 weeks and was therefore non-inferior to Norditropin (11.7cm a year AHV). Sogroya was well-tolerated and had a similar safety profile to its comparator with the most common adverse events observed at rates of 5% or less. The trial’s three-year extension phase is currently ongoing.
REAL 4 shows potential for a once-weekly option for children with GHD, said investigator Bradley Miller, Division of Pediatric Endocrinology, University of Minnesota Masonic Children's Hospital. Novo claims daily injections can be a burden for both children and caregivers and are associated with lack of treatment adherence due to discomfort and pain at the injection site and inconvenience.
“Sogroya essentially allows for a decrease of more than 300 injections a year and that is very meaningful to patients,” Lange explained. Even so, he admitted the firm does not expect a “dramatic switch over” of patients from once-daily treatment to once-weekly treatment. Instead, he said patients who have not yet been treated are likely to opt for Sogroya once it is available.
The Danish major also has plans underway to evaluate the product in Phase III studies for other growth-related disorders including Turner syndrome, Noonan syndrome, idiopathic short stature and small-for-gestational-age. “Following 2026, we hope to see approvals in these other indications which should substantially increase the number of patients,” Lange said.
Novo’s rare disease franchise head Ludovic Helfgott told In Vivo in May that children account for 45% to 50% of the growth-related disorder market. (Also see "How Novo Revitalized Its Rare Disease Operations" - In Vivo, 23 Mar, 2022.)
Rare Endocrine Focus Paying Off
The planned pediatric filing for Sogroya reflects Novo’s broader strategy of building a robust rare disease offering, including a focus on rare endocrine diseases, to complement its better-known diabetes and obesity franchise which is facing emerging competition from Eli Lilly and Company. (Also see "Lilly’s Mounjaro Diabetes Approval Is First Challenge To Novo’s GLP-1 Franchise" - Scrip, 13 May, 2022.)
Helfgott had said GHD was picked as an indication because the firm had deep knowledge in the field and was familiar with physicians and investigators for the disease. The Danish major’s rare endocrine disease products made DKK1.82bn ($179m) in the first quarter, primarily driven by sales of norditropin. (Also see "Novo’s Wegovy Excels But Lilly Rival Hot On Heels" - Scrip, 29 Apr, 2022.)