The treatment, Rybelsus (semaglutide), is used for the control of blood sugar in adult patients with type 2 diabetes, alongside diet and exercise, after approval by the US Food and Drug Administration (FDA).
Rybelsus is a glucagon-like peptide-1 (GLP-1) receptor agonist, which can be delivered in the form of a tablet and is taken once daily.
GLP-1 is often found to be in insufficient levels in those living with type-2 diabetes, with the hormone responsible for slowing digestion, preventing the liver from making too much sugar and helping the pancreas to produce more insulin.
Novo Nordisk’s Rybelsus will become the first oral treatment of this type to be made available to patients, with the company projecting that it will be commercially available in the fourth quarter of 2019.
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” said Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
In clinical trials, Novo Nordisk’s Rybelsus outperformed rival oral treatments, in the form of Januvia (sitagliptin) and Jardiance (empagliflozin), owned by Merck, known as MSD outside of North America and Mexico, and Boehringer Ingelheim, respectively. In comparison trials, the results showed Rybelsus lowered blood sugar more effectively.
Beyond this, Novo Nordisk is also comparing the oral treatment in once-weekly dosing against Januvia’s once-daily schedule, as an add-on treatment to metformin in patients with type 2 diabetes, in a Phase III clinical trial.
The company has also submitted the treatment for approval of a second indication for the reduction of major adverse cardiovascular events in adults with type 2 diabetes and expects a decision by Q1 2020.