FDA Approves First Oral Semaglutide Rybelsus from Novo Nordisk
Editor’s Note: On April 4, Rybelsus was approved in Europe for use in the treatment of Type 2 diabetes.
On September 20, the FDA announced the approval of Rybelsus, an oral drug used to help improve glycemic control in patients with Type 2 diabetes. Manufactured by Novo Nordisk, Rybelsus is the first-ever approved oral GLP-1 treatment. These drugs are used in conjunction with exercise and diet to help maintain and improve outcomes in those with Type 2.
“Before this approval, patients did not have an oral GLP-1 option to treat their Type 2 diabetes, and now patients will have a new option for treating Type 2 diabetes without injections,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
Findings presented at the EASD annual conference in Barcelona, Spain exhibited the efficacy of Rybelsus. The PIONEER trials saw Novo’s GLP-1 demonstrating overall improvement in blood sugar control in Type 2 patients, as well as greater reductions in A1c levels when pitted against competitors Jardiance, Januvia, and Victoza. The PIONEER program saw the enrollment of more than 9,500 participants with T2D across 10 different clinical trials.
Semaglutide for Type 2 diabetes with the brand name Ozempic was first approved as a weekly injection in late 2017 and has been popular and effective for use in Type 2 diabetes. This newly-approved oral, daily version will likely eclipse its predecessor due to ease of use, but Novo Nordisk has larger goals in sight.
According to CEO Lars Fruergaard Jørgensen, this approval will see the company “hopefully take share from some of the existing oral medications.” He went on to say that approximately 70% of patients with T2D are treated with oral therapy, favoring tablets to injections when given the option.
The drug is also under review for approval to reduce cardiovascular events in Type 2 patients with heart disease, with a decision expected by January 20.
The FDA approval of Rybelsus follows a number of exciting new approvals for the management of diabetes. Most recently, the FDA approved two next-generation glucagon treatments for severe hypoglycemia: Baqsimi from Lilly and Gvoke from Xeris Pharmaceuticals.
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