Diabetes Breakthrough: Novo Nordisk’s Rybelsus (Oral Semaglutide), the World’s First Oral GLP-1 Antidiabetic, Approved in Japan!

June 29, 2020 /BioValleyBIOON/ -- Novo Nordisk recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Rybelsus (oral semaglutide) tablets for the treatment of type 2DiabetesAdult patients. The drug is administered orally once daily, and three therapeutic doses (3 mg, 7 mg, and 14 mg) have been approved in Japan. Novo Nordisk will now initiate reimbursement negotiations and expects to launch Rybelsus in Japan thereafter. Novo Nordisk and Merck & Co. will jointly promote Rybelsus in Japan.

Rybelsus is the world’s first and only oral glucagon-like peptide-1 (GLP-1) receptor agonist. Rybelsus is the English brand name for the oral formulation of semaglutide. To date, apart from Japan, Rybelsus has been approved in the United States, the European Union, Switzerland, and Canada as an adjunct to diet and exercise to improve type 2DiabetesBlood Glucose Control in Adult Patients.

Rybelsus’s Regulatory Approval in Japan, Based on PIONEERClinical TrialProject data: This is a global clinical development program comprising eight global and two Japanese Phase IIIa trials, involving more than 9,500 patients with type 2DiabetesAmong the adult patients, approximately 1,300 were from Japan. The approved labeling reflects data from studies in Japanese patients, demonstrating that: (1) once-daily Rybelsus 7 mg has comparable glycemic-lowering efficacy to once-daily liraglutide 0.9 mg; (2) once-daily Rybelsus 7 mg has comparable glycemic-lowering efficacy to once-weekly dulaglutide 0.75 mg; and (3) once-daily Rybelsus 14 mg significantly reduces blood glucose levels compared with liraglutide and dulaglutide. In Japan, liraglutide and dulaglutide are the two most widely used injectable GLP-1 receptor agonists.

Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer at Novo Nordisk, stated: “We are very excited about the approval of Rybelsus in Japan, which is a medication for type 2Diabetes"The patient was provided with the first and only oral GLP-1 medication. It is crucial to offer effective and convenient treatment options for patients with type 2 diabetes, as millions still fail to achieve target blood glucose levels with current oral antidiabetic drugs."

Semaglutide (索马鲁肽) is a glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner, significantly improving blood glucose levels in patients with type 2 diabetes while carrying a low risk of hypoglycemia. Additionally, semaglutide can induceWeight Loss. In addition, semaglutide can significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.

Novo Nordisk has developed an injectable formulation (Ozempic) and an oral formulation (Rybelsus) of semaglutide.

——Ozempic (semaglutide, injection):It is a once-weekly subcutaneous injection formulation (0.5 mg or 1 mg) indicated for: (1) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; (2) to reduce the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

Ozempic was first approved by the U.S. FDA in December 2017 and is currently marketed in 25 countries. The drug’s second indication was approved by the U.S.FDAApproval: Data from the cardiovascular outcomes trial (CVOT) SUSTAIN 6 demonstrated that, in patients with type 2 diabetes at high cardiovascular (CV) risk, Ozempic, when added to standard of care, significantly reduced the risk of the composite major adverse cardiovascular events (MACE) endpoint by 26% compared with placebo.

——Rybelsus (semaglutide, oral tablets):It is a once-daily oral formulation containing the absorption-enhancing excipient SNAC. This medication is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Rybelsus is the world’s first and only oral GLP-1 receptor agonist, administered once daily, with two therapeutic doses: 7 mg and 14 mg.

In the United States, the labeling for Rybelsus was updated in January 2020 to include additional information from the PIONEER 6 cardiovascular outcomes trial (CVOT), which demonstrated cardiovascular (CV) safety. Conducted in patients with type 2 diabetes at high CV risk, the trial showed that Rybelsus, when added to standard care, met its primary endpoint of non-inferiority for the composite major adverse cardiovascular events (MACE) endpoint compared with placebo, thereby establishing CV safety. In the study, the proportion of patients who experienced at least one MACE was 3.8% in the Rybelsus group and 4.8% in the placebo group.

Furthermore, Novo Nordisk is also developing a once-weekly subcutaneous (SC) injection of semaglutide 2.4 mg for weight management in adults with obesity. Semaglutide is a GLP-1 hormone analog that helps people eat less and reduce calorie intake by reducing hunger and increasing satiety, thereby inducingWeight Loss。

Mid this month, Novo Nordisk announced semaglutideWeight LossEfficacy Phase III STEP Program Successfully Completed, Including Four Phase IIIa StudiesClinical Trials. In these trials, semaglutide significantly reduced body weight, with a maximum reduction of 18.2%. (Bioon.com)

Original Source:Rybelsus® approved in Japan for the treatment of type 2 diabetes