Novo Nordisk’s Type 2 Diabetes Drug Gets Greenlight in Korea

Novo Nordisk Korea has announced that the Ministry of Food and Drug Safety has approved Rybelsus, its oral GLP-1 analog treatment for type 2 diabetes. 

“The latest approval is significant as we can provide the world’s first oral GLP-1 analog treatment option for adults with type 2 diabetes in Korea,” said Novo Nordisk Korea CEO Rana Azfar Zafar, adding that the company expects Rybelsus to become an “innovative treatment option” for its target patient population based on its clinically-tested ability to reduce blood sugar levels and control weight. 

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Rybelsus, First US FDA-approved Oral GLP-1 Treatment

Rybelsus (semaglutinide) was the first oral GLP-1 analog treatment to be approved by the US FDA. The tablets help improve control of blood sugar in adult patients with type 2 diabetes, and are taken alongsie diet and exercise. 

The GLP-1 hormone is often found in insufficient levels in type 2 diabetes patients. Rybelsus performs similarly to GLP-1. It slows digestion, prevents the liver from making too much sugar, and helps the pancreas to produce more insulin when needed. 

The treatment comes in three dosage forms — 3mg, 7mg, and 14mg. It does not require drug dose adjustment in patients with liver or kidney dysfunction, or elderly patients. 

In a series of global clinical studies called Pioneer, Rybelsus was proven to beat current oral treatment options, the SGLT-2 inhibitor empagliflozin and the DPP4 inhibitor sitagliptin, in lowering blood sugar levels. The drug also improved control of weight compared to sitagliptin. 

Novo Nordisk also confirmed the drug’s cardiovascular safety profile in type 2 diabetes patients who have cardiovascular disease or risk factors. 

However, Rybelsus treatment may not be suitable for everyone. Common side effects of the drug include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation. Moreover, the drug carries an FDA boxed warning for an increased risk of thyroid cancer. It also has warnings about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury and hypersensitivity reactions.

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Joy Lin

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