The FDA has approved the use of the first GLP-1 agonist in tablet form to reduce the risk of heart attack, stroke, and death from heart disease in people with type 2 diabetes. The drug is Novo Nordisk's Rebelsas (semaglutide).

The US Food and Drug Administration (FDA) has approved a second indication for Rebelsas (semaglutide). It can now be used to prevent heart attacks and strokes, as well as reduce the likelihood of death from cardiovascular disease in adults with type 2 diabetes who are at risk. This was announced in a press release.

The drug from the Danish pharmaceutical company Novo Nordisk became the first oral glucagon-like peptide-1 (GLP-1) receptor agonist approved for use in heart disease. In March last year, the injectable form of semaglutide, Wegovy, received a similar indication.

Drugs in this class mimic the action of a natural hormone that maintains normal blood sugar levels by stimulating insulin production and suppressing glucagon secretion. At the same time, GPP-1 agonists not only help with diabetes and obesity, but also have a cardioprotective effect: they improve metabolism in the myocardium, reduce oxidative stress, prevent apoptosis of heart muscle cells, and lower blood pressure.

As noted, Rebelsas reduced the risk of serious cardiac complications in diabetics by 14% compared to placebo in the SOUL Phase IIIb clinical trial. The sample consisted of 9,650 people who were monitored for four years.

Rebelsas was first registered by the US regulator in September 2019. It was the first tablet-based medication for controlling blood sugar levels in adults with type 2 diabetes.

At the same time, American pharmaceutical giant Eli Lilly is completing research on its oral GLP-1 agonist, orforglipron. An application for its registration will be submitted to the FDA by the end of this year.

In phase III of the ACHIEVE-3 study, it demonstrated superiority over Rebelsas, reducing HbA1c (blood sugar levels over the past 90 days) in type 2 diabetes by an average of 1.9-2.2%, while its Danish competitor reduced it by 1.1-1.4%. In addition, orforglipron helped subjects lose 8.2% of their body weight, while Rebelsas helped them lose 5.3%.

Eli Lilly has not yet studied the effectiveness of its development separately for heart conditions. However, in phase III of ATTAIN-1, orforglipron reduced C-reactive protein levels by almost 47% (produced in response to tissue damage/infection/trauma and may indicate inflammatory processes in the vessel walls) and blood pressure by 5%.

 

Source: PR Newswire