Novo Nordisk, the Danish pharmaceutical company that makes Ozempic, a popular injectable diabetes drug, has received approval from the US Food and Drug Administration (FDA) for Rybelsus, the first oral version of Ozempic1. Rybelsus is a once-daily tablet that contains semaglutide, the same active ingredient as Ozempic, which belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists2. These drugs work by stimulating the pancreas to produce more insulin and reducing the amount of glucose released by the liver3.
Rybelsus is approved for adults with type 2 diabetes who have not achieved adequate blood sugar control with diet and exercise alone, or who are already taking other diabetes medications1. Rybelsus can be used as a standalone treatment or in combination with other drugs such as metformin, sulfonylureas, or insulin. Rybelsus is not indicated for patients with type 1 diabetes or diabetic ketoacidosis, a serious complication of diabetes that occurs when the body produces too much ketones1.
Rybelsus offers convenience and efficacy
According to Novo Nordisk, Rybelsus is the first and only oral GLP-1 receptor agonist that has demonstrated significant reductions in blood sugar and cardiovascular risk in adults with type 2 diabetes. In clinical trials, Rybelsus showed comparable or superior efficacy to other GLP-1 receptor agonists, such as Ozempic, Victoza, and Trulicity, as well as other oral diabetes drugs, such as Januvia and Jardiance. Rybelsus also helped patients lose weight and lower their blood pressure.
One of the main advantages of Rybelsus is that it offers convenience and flexibility to patients who prefer oral medication over injections. Rybelsus can be taken with or without food, at any time of the day, as long as it is taken at least 30 minutes before the first food, beverage, or other oral medication of the day. Rybelsus comes in two doses: 7 mg and 14 mg. Patients start with 3 mg for 30 days and then increase to 7 mg or 14 mg depending on their blood sugar levels and tolerance.
Rybelsus faces competition and challenges
Despite its approval, Rybelsus faces some competition and challenges in the market. Rybelsus is expected to cost about $772 per month in the US, which is similar to the price of Ozempic and other injectable GLP-1 receptor agonists. However, some analysts have questioned whether patients and insurers will be willing to pay a premium for an oral formulation over cheaper generic alternatives or biosimilars. Moreover, Rybelsus may face some safety concerns due to its potential side effects, such as nausea, diarrhea, vomiting, abdominal pain, constipation, and low blood sugar1. Rybelsus also carries a warning about the risk of thyroid tumors and pancreatitis1.
Rybelsus is expected to launch in the US in the fourth quarter of 2023. Novo Nordisk is also seeking approval for Rybelsus in other markets, such as Europe, Japan, China, and Canada. Novo Nordisk hopes that Rybelsus will boost its sales and market share in the global diabetes market, which is estimated to reach $78.2 billion by 2026.
