Novo Nordisk's Rybelsus (Oral Semaglutide) Nears EU Approval Following CHMP Positive Opinion, Already Launched in the U.S.

Feb 07, 2020 14:47 CST Updated 14:47

Novo Nordisk

Insulin Developer and Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.

February 07, 2020 / BIOON -- Diabetes giant Novo Nordisk recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Rybelsus (oral semaglutide) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes whose blood glucose levels are not adequately controlled. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which is expected to make a final decision in early Q2 2020.

Rybelsus is the English brand name for oral semaglutide. In the United States, this medication was approved by the FDA in September 2019 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Notably, Rybelsus is the first and only oral glucagon-like peptide-1 (GLP-1) receptor agonist currently available. It is now marketed in the United States, administered once daily, with approved therapeutic doses of 7 mg and 14 mg.

Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer at Novo Nordisk, stated: “We are very pleased with the CHMP’s positive opinion on Rybelsus, the first and only oral GLP-1 glucose-lowering medication, which has the potential to set a new standard of care for type 2 diabetes in the European Union. Currently, a high proportion of patients with type 2 diabetes do not achieve their target blood glucose levels, highlighting the need for new, more effective solutions to better manage their disease.”

Semaglutide is a glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and suppresses glucagon secretion in a glucose concentration-dependent manner, significantly improving glycemic control in patients with type 2 diabetes while posing a low risk of hypoglycemia.Meanwhile,semaglutideIt can also induce weight loss by reducing appetite and decreasing food intake.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) reducing 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. FDA in January 2020. Data from the cardiovascular outcomes trial (CVOT) SUSTAIN 6 demonstrated that, among patients with type 2 diabetes at high cardiovascular (CV) risk, Ozempic, when added to standard care, statistically 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 adult patients 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 cardiovascular 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. (Bioon.com)

Original Source: Rybelsus® (oral semaglutide) recommended for approval for the treatment of adults with type 2 diabetes by the European regulatory authorities