Novo Nordisk announced that the FDA has approved a new indication of 0.5 mg or 1 mg of Ozempic (semaglutide) for reducing the risk of major adverse cardiovascular events (MACE), such as heart attack, stroke or death, in adults with type 2 diabetes and known heart disease. Additional details about PIONEER 6’s primary endpoint analysis were also added in Rybelsus (oral semaglutide) 7 mg or 14 mg tablets.

Semaglutide is a glucagon-like peptide-1 (GLP-1) analog. It is a hormone that induces insulin secretion and is marketed as Ozempic. The once-weekly injection form was approved by the FDA in 2017 for the treatment of type 2 diabetes. To improve compliance and better long-term results, Novo Nordisk has developed Rybelsus, an oral dosage form of semaglutide, which was approved by the FDA in September 2019.

Cardiovascular disease (CVD) is the leading cause of death and disability in patients with type 2 diabetes. Adults with type 2 diabetes are 2 to 4 times more likely to develop CVD than adults without diabetes.

FDA approval for Ozempic is based on the results of the SUSTAIN 6 Cardiovascular Outcome Trial (CVOT), which assesses the cardiovascular safety of adding Ozempic or placebo to standard treatment for adults with type 2 diabetes and diagnosed cardiovascular disease. In the 2-year SUSTAIN 6 trial, Ozempic significantly reduced the risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke three-component MACE endpoint. Compared to placebo, the estimated MACE relative risk reduction was 26% (HR 0.74 [95% CI: 0.58, 0.95], non-inferiority, median observation time 2.1 years, p <0.001), and the primary composite outcome occurred in 6.6% of Ozempic-treated patients and 8.9% of placebo-treated patients. During the trial, the incidence of gastrointestinal adverse events in the Ozempic group was higher than in the placebo group. Most gastrointestinal adverse events occurred during the first 30 weeks.

Semaglutide promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent mechanism, which can greatly improve blood glucose levels in patients with type 2 diabetes, and has a lower risk of hypoglycemia. At the same time, semaglutide can also induce weight loss by reducing appetite and reducing food intake. In addition, semaglutide can significantly reduce the risk of MACE in patients with type 2 diabetes.

Ozempic (semaglutide, injection preparation) is a weekly subcutaneous injection form (0.5mg or 1mg), which is suitable for: as an adjuvant for diet adjustment and exercise to improve blood glucose control in adults with type 2 diabetes. It also reduces the risk of major adverse cardiovascular events in adults with type 2 diabetes who have cardiovascular disease. Ozempic was first approved by the US FDA in December 2017 and is currently available in 25 countries. Obtained FDA approval for the first time in combination with treatment for adults with type 2 diabetes.

Rybelsus (semaglutide, oral tablet) is a once-a-day tablet that contains an excipient SNAC that promotes absorption. The drug is suitable for: As a diet adjustment and exercise and auxiliary medicine, to improve blood glucose control in adults with type 2 diabetes. Rybelsus is the world’s first and only oral GLP-1 receptor agonist. It is administered once daily with two therapeutic doses: 7 mg and 14 mg. Rybelsus was first approved by the US FDA in September 2019 and is currently under review by multiple regulatory agencies.

Novo Nordisk’s Executive Vice President and Chief Scientific Officer Mads Krogsgaard Thomsen said, “We strongly believe in the therapeutic benefits of semaglutide, and this approval marks a major milestone. Ozempic now provides an effective treatment for patients with type 2 diabetes who have cardiovascular disease in the United States, which can lower blood sugar and reduce cardiovascular risk. We are also very happy that the results of the PIONEER 6 study are reflected on the label of Rybelsus. In order to further evaluate the cardiovascular risk reduction of this drug, we are currently conducting a cardiovascular outcome trial SOUL.”

References:

  1. Novo Nordisk: Ozempic® superior in lowering blood sugar and weight vs placebo, both in combination with SGLT-2 inhibitors