Somatropin(Novo Nordisk A/S)

The FDA first approved Sogroya in August 2020 as a once-weekly treatment for adult growth hormone deficiency. The drug’s label was expanded to include children in April 2023. With a late-stage trial win for its Norditropin heir in hand, Novo Nordisk is making good on plans to boost its profile in the realm of rare disease.Over the weekend, Novo unveiled data from the phase 3 Real8 study, which found that the company’s once-weekly human growth hormone analogue Sogroya was largely on par with its daily predecessor, Norditropin, in a trio of growth disorders in kids.At the basket study’s 52-week mark, Sogroya—first approved in 2020—proved noninferior to Norditropin at improving yearly growth rate in prepubescent children with idiopathic short stature (ISS).Meanwhile, Sogroya demonstrated superiority over Novo’s daily growth hormone in children with Noonan syndrome (NS) and in children born small for gestational age (SGA) when compared to a lower Norditropin dose.When pitted against a higher dose of its growth hormone predecessor in SGA, Sogroya’s efficacy was noninferior, Novo explained in its Monday release.Sogroya was well tolerated in the study, and no new safety flags cropped up that diverged from Norditropin’s long-established profile, the company added.Sogroya’s performance in Real8 allowed the first three sub-studies to meet their primary endpoints. Leveraging data from Real8 and Real9, Novo said it has already filed for approval of Sogroya in SGA, NS and ISS with regulators in the U.S. and Europe.Novo’s Real8 program is also testing Sograya’s mettle in Turner syndrome, though those data won’t arrive until “later this year,” the company said. The FDA first approved Sogroya in August 2020 as a once-weekly treatment for adult growth hormone deficiency. The drug’s label was expanded to include children in April 2023.Sogroya is meant to succeed Novo’s once-a-day growth hormone Norditropin, which has now been on the market for decades. Eli Lilly, Merck & Co. and Pfizer all sell their own daily growth disorder drugs, while newer meds like Ascendis’ Skytrofa and Pfizer’s Ngenla are challenging Sogroya directly on the weekly-dosing front.Novo lumps sales of Norditropin and Sogroya together into its rare endocrine disorders category, which grew sales 31% in 2024 to roughly 5 billion Danish kroner ($745 million).Analytics firm GlobalData has forecast Sogroya will hit $294 million in 2030 sales and expects Norditropin to reach $960 million in sales that same year. The Sogroya results have likely bolstered Novo’s confidence in rare disease, where the company has been playing a “long endgame” since the late 2010s, Ludovic Helfgott, the company’s executive vice president of rare disease, said in a March interview with Fierce Pharma.Aside from drugs for growth disorders like Norditropin and Sogroya, Novo’s rare disease pedigree includes treatments for blood disorders like Esperoct, NovoEight or the recently approved daily hemophilia injection Alhemo, Helfgott explained.Novo plans to stick to those two major disease areas—growth and blood disorders—as it presses forward in the field.“It’s our core, and we will continue to develop this both internally and externally,” Helfgott said.