Japanese approval for Rybelsus as treatment of type 2 diabetes

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Rybelsus (oral semaglutide), the first and only oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a tablet, for the treatment of adults with type 2 diabetes, Danish diabetes care giant Novo Nordisk (NOV: N) announced today.

The approval of Rybelsus in Japan is based on results from the PIONEER clinical trial program, which involved more than 9,500 adults with type 2 diabetes, including around 1,300 adults from Japan. The approved label reflects the Japanese studies, which showed that Rybelsus 7mg once daily was comparable to liraglutide 0.9mg once daily and, in combination with one other oral antidiabetic treatment, Rybelsus 7mg once daily was comparable to dulaglutide 0.75mg once weekly, while Rybelsus 14mg once daily resulted in significantly greater reductions in HbA1c than both liraglutide and dulaglutide - the two most widely used injectable GLP-1 receptor agonists in Japan.

“We are very excited about the approval of Rybelsus in Japan, offering people living with type 2 diabetes the first and only oral GLP-1 in a tablet,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer, adding: “Providing people living with type 2 diabetes with efficacious and convenient treatment options is essential, as millions of people are currently not achieving target blood sugar levels on available oral antidiabetic medications.”