FDA Approves Semaglutide (Wegovy) as First Obesity Treatment to Reduce Major Cardiovascular Events in Adults with Cardiovascular Disease

Mar 09, 2024 05:56 CST Updated 05:57

Novo Nordisk

Insulin Developer and Manufacturer

▎WuXiEdited by Kant Content Team

Today, the U.S. FDA approved a new indication for Novo Nordisk's weight-loss therapy Wegovy (semaglutide) injection, for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight. Semaglutide should be used in conjunction with a low-calorie diet and increased physical activity.According to the FDA press release, semaglutide is the first weight-loss medication approved to assist adults with cardiovascular disease and obesity or overweight in preventing major cardiovascular events.

The FDA press release pointed out that the efficacy and safety of semaglutide for this new indication were primarily demonstrated in a multicenter, placebo-controlled, double-blind trial, which randomly assigned more than 17,600 participants to receive either semaglutide or a placebo. Participants in both groups also received standard-of-care treatment (such as blood pressure and cholesterol management) along with lifestyle counseling on healthy living (including diet and physical activity). The analysis showed,Semaglutide significantly reduced the risk of major adverse cardiovascular events (including cardiovascular death, heart attack, and stroke). The proportion of such events in subjects receiving semaglutide was 6.5%, compared to 8% in the placebo group.

Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, and reduces appetite and 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),It isThe first new drug approved by the U.S. FDA for controlling common obesity or overweight since 2014.The drugAnd later that same year, it received EU approval for the treatment of obesity indications.。

Novo Nordisk mentioned a series of plans regarding the development of semaglutide at the 2024 Capital Markets Day held yesterday.It pointed out that 2.4 mg semaglutide has shown potential in treating obesity-related comorbidities in multiple clinical trials.

▲Semaglutide shows potential in treating obesity-related comorbidities in multiple clinical trials (Image source: Novo Nordisk's official website)

For example, Novo Nordisk inLast AugustPublication of Semaglutide AchievementSELECTThe primary endpoint of the Phase 3 clinical trial,Once-weekly subcutaneous injection of 2.4 mg semaglutide reduces the risk of major adverse cardiovascular events by 20% in overweight or obese adults (patients without a history of diabetes).Published in the same monthSTEP HFpEFResults from the Phase 3 clinical trial also showed,Once-weekly 2.4 mg semaglutide results in a significant improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at 52 weeks in obese adults with heart failure with preserved ejection fraction (HFpEF)., an increase of 16.6 points from baseline, compared to an 8.7-point increase in the placebo group, with an estimated treatment difference of 7.8 points (p<0.001). The KCCQ-CSS is a scale used to measure symptoms and physical limitations in HFpEF patients.

The pooled data analysis of the SELECT and STEP HFpEF trials showed,Compared with placebo, 2.4 mg semaglutide reduced the risk of heart failure hospitalization by 58%.（HR：0.42；95% CI：0.26，0.67），InAnd reduce the risk of hospitalization for heart failure and cardiovascular death by 39%.（HR：0.61；95% CI：0.44，0.84）。

▲Pooled Data Analysis Results of SELECT and STEP HFpEF Trials (Image Source: Novo Nordisk Official Website)

Moreover, in the STEP 9 Phase 3 clinical trial involving 407 obese osteoarthritis patients, 2.4 mg semaglutide demonstrated a clinically significant improvement in pain and physical function.After 68 weeks of treatment, the WOMAC pain score decreased by 41.7 in the semaglutide group and by 27.5 in the placebo group, with an estimated difference of 14.14 points (95% CI: -19.98, -8.30).

▲ Semaglutide Improves Pain in Obese Osteoarthritis Patients (Image Source: Novo Nordisk's Official Website)

In addition to the 2.4 mg injectable dose, Novo Nordisk's semaglutide-related pipeline also includes the development of a 7.2 mg higher-dose injectable formulation, 25/50 mg oral formulations, and CagriSema (a fixed-dose combination of semaglutide and the long-acting amylin analogue cagrilintide).

▲Novo Nordisk's pipeline of various weight-loss therapies, including semaglutide (Image source: Novo Nordisk's official website)

Among them,CagriSema Demonstrates Positive Weight Loss Effects in a 20-Week Phase 1 Trial, with Patients Achieving a 17.1% Reduction in Body Weight, Compared to Only 9.8% in the Semaglutide Group.Currently, there are five Phase 3 clinical trials related to CagriSema ongoing.

▲CagriSema Shows Positive Weight Loss Effects(Image source: Novo Nordisk's official website)

▲Five ongoing Phase 3 trials of CagriSema(Image source: Novo Nordisk official website)

Reference Reading:Weight Loss Exceeds 13% in 12 Weeks! Latest Results and Company Development Strategy for Novo Nordisk's Next-Generation Weight Loss Therapy Announced

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References:

[1] FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. Retrieved March 8, 2024 from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or

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