Rybelsus (semaglutide) New Label Update Allows for Early Use in Type 2 Diabetes Treatment

Rybelsus (semaglutide) New Label Update Allows for Early Use in Type 2 Diabetes Treatment

Since its initial FDA approval in 2019, Rybelsus has been prescribed to hundreds of thousands of patients to improve glycemic control along with proper diet and regular exercise.

Novo Nordisk announced in a press release last week that a label update for their type 2 diabetes treatment Rybelsus (semaglutide) was approved from the US Food and Drug Administration (FDA). The approval allows for earlier intervention and treatment with Rybelsus in adults with type 2 diabetes, when previously it was not approved as an initial (first-line) treatment option.

Since its approval, Rybelsus has been prescribed to hundreds of thousands of patients to improve glycemic control in conjunction with proper diet and regular exercise. It is the first and only oral glucagon-like peptide (GLP-1) analog available as an initial therapy to help lower A1C levels (a hemoglobin A1C test to measure average blood sugar over the past three months). The tablet medication can be used by adults with type 2 diabetes who have not previously used diabetes treatments.

Type 2 diabetes typically occurs in older adults but the number of children developing the disease is increasing due to rising obesity and inactivity. The body becomes resistant to insulin and can no longer use glucose properly as a fuel, so glucose begins circulating in the bloodstream and may lead to problems with the circulatory, nervous and immune systems.

Although there is no cure for type 2 diabetes, losing weight, eating a healthy diet and exercising helps manage it. Often, diabetes medication or insulin therapy are used as management tools.

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A New Approach to Diabetes Management in Rybelsus’ Formulation

Rybelsus works somewhat differently than other diabetes medications to lower blood sugar. It has three main mechanisms of action: increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the liver and slowing down the process of food leaving the stomach after eating. The semaglutide functions like GLP-1 would, in that it can promote insulin secretion based on blood glucose levels by binding to receptors on the pancreatic β cells, and acts like a physiological regulator of appetite.

The medication itself is a novel co-formulation of semaglutide and SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate), an absorption enhancer that promotes the absorption of the semaglutide in the stomach. This combination is essential in the success of the pill format of Rybelsus. The pills are available as a 7 mg or 14 mg dose.

The most common side effects associated with Rybelsus include nausea, stomach pain, decreased appetite and other gastrointestinal symptoms. There are some more serious side effects to be aware of, including pancreatitis, kidney failure and potentially thyroid tumors or thyroid cancer.

Cost of Rybelsus

Type 2 diabetes patients will be able to easily access Rybelsus as a treatment option. Novo Nordisk is working with health insurance providers to make sure there is broad patient coverage and access to the treatment. As such, insured patients could pay only $10 for a one-to-three-month prescription.