The First And So Far The Only Injectable GLP-1 Oral Drug, Rybelsus, Is Licensed

Novo Nordisk's oral GLP-1 agonist, Rybelsus, which injects growth into a key part of its diabetes franchise program, has been approved for marketing in Japan.Japan's Ministry of Health, Labor and Welfare (MHLW) issued after FDA approval of Rybelsus (semaglutide) in October last year and approved a recommendation in the European Union in February.

Rybelsus is the first and only oral alternative to injectable GLP-1 agonists to date, such as Eli Lilly's Trulicity (dulaglutide) and Novo Nordisk's Ozempic (semaglutide) and Victoza (liraglutide), which are considered future blockbuster brands.

Rybelsus has been approved by the Pioneer Clinical Trial Program in Japan, which was conducted in 9500 subjects, including 1300 patients in Japan.In this study, a 7 mg daily dose of Rybelsus was equivalent to a weekly dose of Trulicity to control blood glucose, whereas a 14 mg daily dose was superior to Trulicity and Victoza, which were injected once a day.

New data from the PIONEER program, reported earlier this month at the American Diabetes Association meeting, show that Rybelsus is more effective than the oral DPP-4 inhibitor Januvia (sitagliptin) by Merck & Co in reducing blood glucose and weight in patients with type 2 diabetes, the SGLT2 inhibitors Jardiance (empagliflozin) by Boehringer Ingelheim and Eli Lilly, and Victoza.

Analysts believe that clinical performance and patient-friendly doses can boost Rybelsus to more than $2 billion in products, which some estimate may be even higher.

Globally, the incidence of diabetes continues to rise and is poorly controlled.On average, about 4,000 people are diagnosed with diabetes every day in the United States, and about 8% of the total U.S. population is affected by diabetes, one-third of whom do not know they are already ill.According to the latest survey of epidemiological data of diabetes in China, the diabetes rate of the total population in China is twice as high as that in 2001 and four times as high as that in 1994. The number of patients is about 41 million, and the number of diabetic patients is about 20 million.The huge demand is the basis for the rapid growth of diabetes drug market in mainland China, and it is also a reason why semaglutide, as the most effective ingredient of diabetes drug at present, is so popular in the market.

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