Semaglutide Wins FDA Label Update

On Jan. 12, 2023, Novo Nordisk announced the US Food and Drug Administration (FDA) approved a label update to permit first-line use of semaglutide (Rybelsus) in adult patients with type 2 diabetes (T2D).

 

Novo Nordisk’s Rybelsus is available as white, oral tablets in 3mg, 7mg and 14mg doses.

New indication

An FDA-granted label update for semaglutide, an oral glucagon-like peptide-1 (GLP-1) receptor agonist sold by Novo Nordisk under the brand name Rybelsus, replaces the drug’s prior label limitation prohibiting its use as an initial therapy for T2D. Now providers can prescribe semaglutide even to patients who have never taken a diabetes medication before. Previously, most providers looked to prescribe this agent only after a patient had tried a first-line drug such as metformin without success.

According to the company’s press release, update applies to the 7 mg and 14 mg tablets of the the first-and-only oral GLP-1 analog, along with diet and exercise, as initial therapy improve glycemic control in patients with type 2 diabetes.

Mechanism of action

Semaglutide is an analog of the GLP-1 hormone, which has multiple effects on glucose as mediated by the GLP-1 receptors. The drug selectively binds to and activates the GLP-1 receptor stimulating insulin secretion and decreasing glucagon secretion. It lowers blood sugar levels in three ways, by:

  1. Increasing the release of insulin from the pancreas when blood sugar is high
  2. Decreasing the release of sugar from the liver
  3. Slowing the process of food leaving the stomach after eating

 

In 2019, the FDA first approved Rybelsus based on the results from the PIONEER series of clinical trials, in which the oral semaglutide formulation was shown to more effectively lower blood sugar than sitagliptin and empagliflozin. Although not approved for weight loss, Rybelsus also resulted in an average five-pound reduction in body weight in PIONEER study participants.

Semaglutide formulations

Most drugs within the class of GLP-1 receptor agonists, despite their clinical benefits, require subcutaneous self-injection, which may pose a clinical challenge for patient adherence. Novo Nordisk’s Rybelsus offers an oral semaglutide option for patients who are unable or unwilling to self-administer an injectable agent. The two injectable versions of semaglutide currently FDA approved for use in the U.S. are Wegovy and Ozempic, which are both also made by Novo Nordisk.

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