Novo Nordisk’s GLP-1 for Type II diabetes approved for first-line treatment

Rybelsus, Novo Nordisk’s GLP-1 also known as semaglutide, snagged a label update from the FDA, allowing patients to take it as a first-line treatment for Type II diabetes in 7 or 14 mg, the company announced.

The update came after its initial approval in 2019, when the drug hit the market as the first GLP-1 pill to enter the Type II diabetes market. And it remains the only one. It’s an analog of the hormone glucagon-like peptide-1 (GLP-1).

After approval, analysts pegged it as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Until now, Rybelsus could only be used after patients had tried other treatments.

Novo Nordisk reported in 2021 that 80% of Rybelsus prescriptions were to patients who were new to GLP-1 category drugs.

Doug Langa

“In the U.S., hundreds of thousands of people with type 2 diabetes have been prescribed this medicine as part of their type 2 diabetes treatment regimen to help lower their A1C,” Doug Langa, EVP of North America operations and president of Novo Nordisk, said in a statement.

A1C is a technical medical term referring to the percentage of sugar-coated hemoglobin proteins in a person’s red blood cells.

Langa added that the drug remains “a pivotal part” of the company’s portfolio.

Rybelsus works by using semaglutide and SNAC, an absorption enhancer for semaglutide in the stomach, to increase insulin production from the pancreas while simultaneously decreasing sugar release from the liver and slowing down food leaving the stomach.

Pfizer recently joined the GLP-1 race with PF-07081532, a GLP-1 agonist. In December 2022, Pfizer began Phase II trials in its partnership with Sosei Heptares to test the candidate on patients with either Type II diabetes or obesity. In the trial, along with a placebo or the candidate, some patients with Type II diabetes will also be randomized to Novo Nordisk’s Rybelsus.

Eli Lilly also has tirzepatide, marketed as Mounjaro, which won approval in 2022 for adults with Type II diabetes. Novo Nordisk has two other semaglutide brands, Ozempic and Wegovy. Ozempic was approved in 2017 for patients with Type II diabetes, while Wegovy was approved as a weekly injection for weight management.

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