Semaglutide Receives CHMP Positive Opinion for Heart Failure with Preserved Ejection Fraction in Europe

Sep 23, 2024 09:20 CST Updated 09:20

Novo Nordisk

Insulin Developer and Manufacturer

｜Edited by the Peptide Biotech Content Team

September 20, 2024Day,Novo Nordisk Announces 2.4mg Wegovy (Semaglutide) Receives CHMP Positive Opinion for the Treatment of Obesity-Related Heart Failure with Preserved Ejection Fraction (HFpEF). This drug is the first GLP-1 medication recommended for approval to treat heart failure.

The CHMP's recommendation for approval this time is mainly based on the positive results of two Phase III studies (STEP HFpEF and STEP HFpEF-DM).

In the placebo-controlled STEP HFpEF trial (n=529), after 52 weeks of treatment, 2.4mg Wegovy not only reduced body weight in obese patients with HFpEF without type 2 diabetes (-13.3% vs. -2.6%, p<0.001), but also alleviated heart failure-related symptoms in these patients (p=0.001). Additionally, exercise function was significantly improved.

In the placebo-controlled STEP HFpEF-DM study (n=616), after 52 weeks of treatment, 2.4mg Wegovy reducedObese Patients with Type 2 Diabetes and HFpEFThe body weight (-9.8% vs. -3.4%, p<0.001) can also reduce heart failure-related symptoms in these patients (p<0.001). Additionally, the exercise capacity of the patients was significantly improved.

About Semaglutide

Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, reduces appetite, and decreases food intake. Semaglutide was initially developed as a treatment for type 2 diabetes.ApprovedLaunched (Trade Name: Ozempic), in view of its significant effect on weight loss, the FDA in June 2021ApprovalIt is used to treat ordinary obese patients (trade name: Wegovy), which is the first new drug approved by the US FDA for controlling common obesity or overweight since 2014. The drug was further approved by the EU for the treatment of obesity indications later in the same year.

AboutNovo Nordisk

Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this goal, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, providing products and services to more than 168 countries and regions globally.

Source:

1.Pharmcube

2.Novo Nordisk