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# Novo Nordisk GLP-1 Approved for Diabetes
- URL: https://www.fdaweb.com/novo-nordisk-glp-1-approved-for-diabetes/
- Published: 2019-09-20T12:00:00.000Z
- Updated: 2026-09-15T01:51:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145055

FDA has approved Novo Nordisk’s Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 diabetes, along with diet and exercise. The agency says this is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the U.S. that does not need to be injected.

GLP-1, which is a normal body hormone, is often found in insufficient levels in Type 2 diabetes patients. “Like GLP-1, Rybelsus slows digestion, prevents the liver from making too much sugar, and helps the pancreas produce more insulin when needed,” an [agency release](http://s2027422842.t.en25.com/e/es?s=2027422842&e=256042&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=e673f2de0d7e4ede82ffa71f0668d621&elqaid=9560&elqat=1&ref=fdaweb.com) says.

  
The approval was based on data showing that Rybelsus as a stand-alone therapy resulted in a significant reduction in blood sugar (hemoglobin A1c) compared with placebo, FDA says. “After 26 weeks, 69% of those taking 7 mg once daily and 77% of those taking 14 mg once daily of Rybelsus decreased their HbA1c to lower than 7%, compared with 31% of patients on placebo,” it says.

On the safety side, the therapy includes a boxed warning about the potential increased risk of thyroid c-cell tumors, and that Rybelsus is not recommended as the first choice of medicine for treating diabetes. Patients who have ever had an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2) are advised not to use Rybelsus, FDA says. The drug also has warnings about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury and hypersensitivity reactions.