Rybelsus FDA approval : Danish pharma company Novo Nordisk has bagged approval from the US Food and Drug Administration (FDA) for Rybelsus (semaglutide) oral tablets for its use in patients with type 2 diabetes.
The FDA approval for Rybelsus is to improve control of blood sugar in addition to diet and exercise in adults having type 2 diabetes.
The US drug regulator said that Rybelsus is now the first glucagon-like peptide (GLP-1) receptor protein treatment to be approved in the US that does not require to be injected. GLP-1 drugs are non-insulin treatments for type 2 diabetes.
According to the FDA, GLP-1 is a normal body hormone found usually in insufficient levels in type 2 diabetes patients. Like GLP-1, Rybelsus slows down digestion, stops the liver from making too much sugar, and enables the pancreas to generate more insulin when required.
Commenting on Rybelsus FDA approval, Lisa Yanoff – acting director of the Division of Metabolism and Endocrinology Products in the FDA Center for Drug Evaluation and Research, said: “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.
“Before this approval, patients did not have an oral GLP1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.”
Rybelsus FDA approval is based on the findings of 10 PIONEER clinical trials which featured 9,543 adults having type 2 diabetes. The GLP-1 drug was shown to have more effectively reduced blood sugar compared to sitagliptin and empagliflozin.
Also, treatment with Rybelsus delivered up to 4.4 kg loss in body weight. Rybelsus showed a safe and well-tolerated profile throughout the PIONEER clinical program, with mild to moderate nausea being the most common adverse which went away over time.
Rybelsus should be taken at least 30 minutes prior to the first food, beverage or other oral drugs for the day, with less than 4 ounces of plain water.
Mads Krogsgaard Thomsen – executive vice president and chief science officer of Novo Nordisk, commenting on Rybelsus FDA approval, said: “We are very excited that we can make the first oral GLP-1 available in the US and thereby expand the treatment options for adults living with type 2 diabetes.
“Novo Nordisk has a very long legacy of developing innovative injectable medicines for people living with diabetes and, with the approval of Rybelsus, we are now able to bring our innovation into the market for oral antidiabetics.”
Novo Nordisk is looking to launch Rybelsus for adults with type 2 diabetes in the US in the fourth quarter of this year.
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