Novo Nordisk Korea said Monday that the Ministry of Food and Drug Safety approved Rybelsus, the world's first oral GLP-1 analog treatment for type 2 diabetes.
The treatment, which comes in three dosages – 3mg, 7mg, and 14mg- is a semaglutide drug that patients with insufficient control over their type 2 diabetes can take once a day to improve blood sugar levels alongside diet and exercise.
Rybelsus does not require drug dose adjustment in patients with renal dysfunction, hepatic dysfunction, or elderly patients.
The company has proved the efficacy and safety profile of Rybelsus in adults with type 2 diabetes mellitus through several large-scale global clinical studies called PIONEER.
The trials confirmed that the treatment has a superior blood sugar-lowering effect than empagliflozin of the SGLT-2 inhibitor class and sitagliptin of the DPP4 inhibitor class, the two existing oral therapeutics, and the advantage of ancillary weight control compared to sitagliptin.
The company also confirmed the cardiovascular safety profile of Rybelsus compared to placebo through a study participated in by patients with type 2 diabetes who had cardiovascular disease or cardiovascular risk factors.
"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," Novo Nordisk Korea CEO Rana Azfar Zafar said. "The company expects Rybelsus to become an innovative treatment option for adults with type 2 diabetes based on the benefits of superior blood sugar reduction and weight control confirmed through large-scale clinical trials."
Novo Nordisk will strive to improve the quality of life of diabetic patients through continuous innovation as a global leader in diabetes treatment, he added.