Novo obesity drug protects heart health in large trial
08 Aug 2023
Drug ApprovalAHA
Wegovy, one of several drugs now surging in popularity due to their potent weight-loss effects, can also protect the heart, according to results from a large international study called SELECT.
The findings could catapult use of the drugs, known as GLP-1 agonists, even higher, and spur further changes in how doctors treat obesity. They're also a major boost to Wegovy maker Novo Nordisk, which holds pole position in a pharmaceutical industry race to make GLP-1 drugs the next multibillion dollar market.
Announced by Novo Tuesday, the study found treatment prevented heart attacks and strokes in overweight people with heart disease, reducing by 20% versus placebo their relative risk of cardiovascular complications and death.
Novo analyzed the results after 1,270 instances of heart attacks, strokes or cardiovascular death among study participants. Novo said “all three components” contributed to the reported risk reduction, suggesting a treatment benefit on each measure.
“People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death,” said Martin Holst Lange, Novo’s head of development, in the company’s statement. “SELECT is a landmark trial and has demonstrated that [Wegovy] has the potential to change how obesity is regarded and treated.”
Novo said it will ask regulators in the U.S. and Europe this year to expand Wegovy’s label to include the new data. It plans to share detailed study findings at a medical meeting in 2023.
But the new data Tuesday are the first time a weight-loss drug, when added to changes in diet and exercise, proved cardio-protective in a broad group of people. Unlike prior heart trials of Ozempic, which were limited to people with Type 2 diabetes, SELECT enrolled non-diabetic participants. It was particularly large, too, involving more than 17,000 adults across more than 40 countries.
Analysts view this kind of trial evidence as necessary to convince insurers to pay for Wegovy and other GLP-1 medicines like Ozempic that are being used for weight loss off-label. Many payers have been reluctant to widely cover them, while Medicare, the government insurance program for people 65 years or older, is prohibited by law from paying for weight-loss drugs.
“We definitely know these drugs work for weight loss,” Martha Gulati, director of preventive cardiology at Cedars-Sinai Medical Center, said in an interview. “In terms of accessing these medications, it’s quite the challenge. We do need to convince the insurers.”
Despite insurers’ resistance, GLP-1 drugs are in such demand that Novo can’t make Wegovy or Ozempic fast enough. Both are currently in shortage in the U.S.
Their popularity extends beyond doctors’ offices, with celebrities crediting Ozempic or Wegovy for their weight loss and TikTok videos racking up hundreds of millions of views. In some cases, people are willing to pay cash for the medicines, which cost between $900 and $1,400 for a typical month’s supply.
A recent survey of U.S. adults by the Kaiser Family Foundation found 70% had heard at least a little about “new weight-loss drugs.” Forty-five percent were either very or somewhat interested in taking them, although fewer remained interested if treatment wasn’t covered by their insurance.
In diabetes, GLP-1 drugs work by increasing the body’s production of insulin, thereby helping control blood sugar. They’re also thought to reduce appetite and increase a sense of post-meal fullness, furthering their effects on weight.
While they’re generally seen as safe, they do come with a range of possible side effects, including pancreatitis and kidney injury. Their surging use has also prompted regulators to probe other safety concerns, such as whether they’re associated with suicidal thoughts.
In SELECT, Wegovy “appeared to have a safe and well-tolerated profile” that was similar to previous testing, Novo said.
Industry experts estimate sales of GLP-1 drugs could reach as high as $50 billion by the end of the decade. Behind Novo stretches a line of competitors led by Eli Lilly and also including Pfizer and Amgen.
Lilly is seen as a particularly formidable competitor. Its drug Mounjaro, which targets GLP-1 and another hormone called GIP, is already approved in the U.S. for diabetes. In further testing, Mounjaro was found to help people lose up to one-fifth of their body weight — higher than what Wegvoy showed in Novo’s trials.
These types of trials need to be particularly lengthy and large to detect a difference between drug and placebo on slow-emerging cardiovascular risk. SELECT is following participants for up to five years, for instance.
Because of this, their findings can be particularly persuasive. Similar types of cardiovascular studies were used to prove that an earlier class of diabetes drugs, called SGLT-2 inhibitors, were also beneficial in treating heart failure.
Novo and Lilly hope that their respective testing of GLP-1 drugs will bring a comparable rethink in how the treatments are used.
The results “should be meaningful for payers to drive improved coverage,” perhaps leading Medicare to start paying for Wegovy by the middle of 2025, wrote Jefferies analyst Peter Welford, in a note to investors on Tuesday.
Novo shares rose by 17% in Tuesday trading on the New York Stock Exchange, adding tens of billions of dollars to the company’s market valuation.
Ben Fidler contributed writing.
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