Novo Nordisk Snags FDA Approval for Oral Type 2 Diabetes Drug

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Novo Nordisk’s oral-semaglutide for type 2 diabetes snagged approval from the U.S. Food and Drug Administration (FDA) late Friday, marking it as the first such treatment to be approved in pill form.

Marketed under the brand name Rybelsus, the approval under Priority Review marks a significant leap forward for diabetes patients due to the pill form of the drug. Rybelsus, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist, is part of a class of drugs that has been used to treat diabetes patients since 2005. But with the oral form, it’s a new day for patients who typically have to inject their medications.

Todd Hobbs, U.S. chief medical officer of Novo Nordisk, told BioSpace earlier this year that new technologies have made this year among the most exciting for diabetes patients due to the advancement of treatment options. In an earlier interview, Hobbs, who is also a diabetic, touted the clinical success of Rybelsus, which includes standing up against established diabetes treatments like Eli Lilly’s Jardiance and Novo’s own Victoza. Hobbs said it was important for patients that the same efficacy can be found in the pill form of Rybelsus that other drugs have delivered via injectable.

During 10 different Phase III clinical trials, Rybelsus was shown to reduce A1C and also help patients reduce their body weight. In PIONEER 2, semaglutide demonstrated a superior A1C reduction of 1.3% compared to a 0.9% reduction with Jardiance at 26 weeks and a statistically significant reduction in A1C for the secondary endpoint at 52 weeks. In PIONEER 4, semaglutide demonstrated a non-inferior reduction in A1C versus Victoza and a superior reduction versus placebo at 26 weeks. At 52 weeks, semaglutide demonstrated statistically significant reductions in A1C against both Victoza and placebo.

“People living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual A1C goals,” Hobbs said in a statement following approval of Rybelsus. With Rybelsus, we have the opportunity to expand use of effective GLP-1 receptor agonist therapy by providing adults with type 2 diabetes an oral medication which was previously only available as an injection to help with managing their blood sugar.”

Type 2 diabetes impacts more than 28 million people in the U.S. alone. Despite the available treatment options, many adults with type 2 diabetes have poorly managed blood sugar that can increase the risk of developing serious diabetes-related complications. The FDA is continuing to review Rybelsus for another indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Novo Nordisk said it anticipates a decision on that indication in the first quarter of 2020.

In August, Novo Nordisk acquired a Purdue Pharma manufacturing site in Durham, N.C. to bolster the manufacture of Rybelsus. The Durham site will reinforce the development of the company’s diabetes treatments at an existing Clayton, N.C. facility and its manufacturing facilities in Denmark.

Injectable semaglutide has already been approved by the FDA under the brand name Ozempic as a type 2 diabetes treatment. Ozempic was approved in December 2017 and was launched for commercialization in the U.S. in early 2018.

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