Initial data from Novo Nordisk’s Phase III trial on Sogroya (somapacitan) to treat growth hormone deficiency (GHD) demonstrated safety and efficacy in prepubertal children.
Courtesy of Joreks
Initial data from Novo Nordisk‘s Phase III trial evaluating Sogroya (somapacitan) to treat growth hormone deficiency (GHD) demonstrated safety and efficacy in prepubertal children.
In its presentation at the Endocrine Society’s annual meeting in Atlanta, Novo Nordisk shared preliminary results from the REAL 4 (REversible ALbumin) trial on the use of the injectable drug Sogroya in kids with growth disorders.
The study enrolled 200 growth hormone (GH) treatment-naive children, where 2:1 received either 0.16 mg of Sogroya subcutaneously once a week or 0.034 mg/kg of Norditropin (somatropin) subcutaneously daily. Notably, Norditoprin is also Novo Nordisk’s product, which already has U.S. Food and Drug Administration approval for children and adults with GHD.
The randomized, multi-national, open-label REAL 4 study was designed with a 52-week main phase, to be followed by a three-year extension. Sograya is already FDA-approved for adults with GHD and is the first therapy of its kind to be administered weekly, compared to Norditropin and other similar drugs to be given daily.
“The existing treatment options available for children with growth hormone deficiency require daily injections for many years. Based on the results of the REAL 4 study, there is potential for a once-weekly option for children with growth hormone deficiency,” Dr. Bradley Miller, M.D., Ph.D., division of pediatric endocrinology at the University of Minnesota Masonic Children’s Hospital, said in a statement.
GHD is a rare disease characterized by insufficient amounts of growth hormone in the body. This hormone is necessary for bone strength and proper muscle growth, as well as for regulating fat and sugar levels. Sogroya is a human growth hormone analogue that is given to patients who are unable to make enough GH. Aside from being approved in the U.S. for adults, it is also approved in Australia, Japan, Europe and Saudi Arabia.
“We are excited about the REAL 4 phase III study results showing that the weekly use of Sogroya worked as well as daily treatment with Norditropin (somatropin) injection. Sogroya shows Novo Nordisk’s commitment to the rare endocrine community and our continued vision to deliver innovative therapeutic solutions for all patient needs,” Martin Lange, executive vice president and head of development at Novo Nordisk, said in a statement.
Novo Nordisk is one among a few companies seeking solutions for rare growth-related diseases in children. BioMarin Pharmaceutical’s Voxzogo (vosoritide) received the FDA’s approval in 2021 to improve growth in kids ages five years and older with achondroplasia, a type of dwarfism. Voxzogo is given once a day via injection.
