FDA Approves Novo Nordisk's Growth Disorder Treatment For New Populations
By Katherine Hamilton
Novo Nordisk received approval from the Food and Drug Administration for three new indications of Sogroya, a growth hormone.
Sogroya is now indicated for kids aged 2.5 years and older with disorders affecting their height, including idiopathic short stature, short stature born small for gestational age, or growth failure associated with Noonan Syndrome.
It is also indicated for children of the same age group and adults with growth hormone deficiency.
Sogroya is a once-weekly injection which comes in 5 mg, 10 mg and 15 mg dosages.
Novo Nordisk has been studying Sogroya as a way for people with growth disorders to avoid daily injections. In a study, Sogroya demonstrated non-inferiority compared with daily somatropin and growth hormone dosages.
Novo Nordisk also submitted a supplemental application for Sogroya's approval in the U.S. for Turner Syndrome. A decision is expected later this year, the company said.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
February 27, 2026 16:33 ET (21:33 GMT)
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