FDA approves Wegovy for reducing heart disease risk

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

The FDA approved a new use for a drug to reduce the risk of serious heart problems in adults with cardiovascular disease and either obesity or overweight.

FDAOffice of the Commissioner

In great news for Novo Nordisk, Wegovy has passed FDA approval for reducing the risk of serious heart problems in adults who are considered obese or overweight.

Wegovy is the only GLP1 Receptor Agonist to be approved officially (by the FDA) for chronic weight management in 2021, and now it's been approved as well for reducing heart disease risk.

While many are still skeptical of how useful GLP1 Receptor Agonists (Ozempic, Wegovy, Mounjaro, Zepbound, and other) are, the FDA has reveiwed the literature and available information and come to a decision which makes a lot of sense.

While there's reason for caution (many of the key studies have been funded in part at least by Novo Nordisk), it's great to have the governing body in the US make this decision.

The FDA had some really great notes on the measured safety and efficacy of Wegovy to date:

Wegovy’s safety and efficacy were studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo.

The largest placebo-controlled trial enrolled adults without diabetes. The average age at the start of the trial was 46 years and 74% of patients were female. The average body weight was 231 pounds (105 kg) and average BMI was 38 kg/m2. Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo. Another trial enrolled adults with type 2 diabetes. The average age was 55 years and 51% were female. The average body weight was 220 pounds (100 kg) and average BMI was 36 kg/m2. In this trial, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo. 

I've you'd like to learn more about Novo Nordisk the company, there's a great segment on Acquired about it, which we wrote about:

Acquired did an episode on Novo Nordisk, the company behind Semaglutide (Ozempic, Rybelsus)

The folks over at the Acquired podcast have put together a fantastic deep dive podcast on Novo Nordisk, and it’s a great listen. What is Novo Nordisk? Novo Nordisk (Wikipedia) is the multinational pharmaceutical company from Denmark which invented Semaglutide. While the name “Semaglutide” may not mean much, it’s the

GLP1 GuideGLP1.Guide Staff

The news has also been picked up by the media:

Novo Nordisk’s Wegovy wins FDA approval for cutting heart disease risks, in move that could expand insurance coverage

That decision could widen insurance coverage for the drug and similar treatments for obesity, which has been a major barrier to access for patients.

CNBCAnnika Kim Constantino

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