Novo Nordisk said Thursday it will seek federal approval to expand the use of its Ozempic and Rybelsus pills to kids and teenagers with Type 2 diabetes.
The Danish drugmaker expects to file its request with the Food and Drug Administration in the second half of this year. The agency’s reviews take between six and 10 months.
Plans to give minors ages 10 to 17 access to the GLP-1 drugs come after a Stage 3 clinical trial showed they were effective at controlling blood sugar with limited side effects.
The yearlong trial had more than 130 participants and specifically looked at oral forms of the medications. Ozempic is also available as a weekly injection for adults, though a pill form is set to launch soon. Rybelsus, which is also approved for adult use, exists only as a pill.
No oral GLP-1s are approved by the FDA for kids and teenagers with Type 2 diabetes. Several injections in this drug class made by other companies are available, however.
Longstanding first-line treatments for youth-onset Type 2 diabetes include insulin and metformin, an older medication that treats high blood sugar levels.
Metformin provides long-term blood sugar control to only about half of patients in this age group, according to a 2012 study published in the New England Journal of Medicine.
The Centers for Disease Control and Prevention estimates some 14,000 minors in the U.S. are diagnosed with Type 2 diabetes each year, a figure that’s widely expected to grow in the coming decades.
The condition develops when the body struggles to use insulin produced by the pancreas to keep blood sugar in check. Type 1 diabetes, by contrast, occurs when the body makes little to no insulin.
Minors who are overweight, eat a poor diet or don’t get enough physical activity have a higher chance of getting Type 2 diabetes, the CDC says.
Other risk factors include a family history of the condition and having a mother who became diabetic during pregnancy. Black, Hispanic, Native American and Asian American youth are also more likely to have the disease.