Positive Phase III results for Novo Nordisk’s once-weekly Sogroya

Novo Nordisk (NOV: N) today presented data from the Phase III REAL8 basket study, which showed that once-weekly Sogroya (somapacitan) was non-inferior to its own once-daily growth hormone Norditropin (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA), or with Noonan syndrome (NS), or with idiopathic short stature (ISS).

In addition, the Danish drugmaker noted, superiority was achieved for once-weekly Sogroya versus daily growth hormone in children with NS, as well as compared to lower doses of daily growth hormone in children born SGA.

REAL8 data showed that Sogroya was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone. Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya was similar to those treated with daily growth hormone. Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark.