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FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.
FDA has approved Rybelsus (semaglutide) oral tablets from Novo Nordisk for improving control of blood sugar in adult patients with type 2 diabetes. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected, FDA announced in a Sept. 20, 2019 press release. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.
Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. 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, according to FDA.
"GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment," said Vanita R. Aroda, MD, director of Diabetes Clinical Research, Brigham and Women's Hospital, Boston, MA, and a clinical trial investigator, in a press release issued by Novo Nordisk. "The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals."
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and [FDA] welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” said Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, in the agency’s press release. “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.”
Rybelsus is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg, and will be available in the US beginning in the fourth quarter of 2019. Initial supply will come from manufacturing facilities in Denmark; however, future supply will come from manufacturing facilities in the US, Novo Nordisk stated. In 2015, Novo Nordisk made a strategic investment to build a new manufacturing facility in Clayton, NC, to prepare for the future demand for the drug. Additionally, earlier in 2019 Novo Nordisk acquired a tableting and packaging facility in Durham, NC, to meet anticipated supply needs for Rybelsus.
Novo Nordisk is working with health insurance providers with a goal of ensuring broad insurance coverage and patient access to the product. A savings card program will be available at the time of launch for eligible commercially insured patients to keep out-of-pocket costs down to as little as $10 a month.
FDA is still reviewing Novo Nordisk's new drug application for Rybelsus seeking an additional indication to reduce the risk of major adverse cardiovascular events, such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (CVD). A decision is expected in the first quarter of 2020.
The drug is also currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.