Novo Nordisk’s U.S.-listed stock jumped rose 13% early Tuesday, after the company said its obesity treatment semaglutide, marketed as Wegovy, met its main goal in a trial evaluating its ability to reduce cardiovascular events and not just help with weight loss.
The results are an important win for the obesity category, Wolfe Research said in an early note.
” This has been a very heavily anticipated readout, and is a clear win not only for NOVO, but also for LLY and the obesity category at large. Results are VERY strong,” analysts led by Dr. Tim Anderson wrote in a note to clients.
The Danish company
NVO,
NOVO.B,
said a 2.4 mg dose of semaglutide reduced the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the trial called Select compared with placebo.
“The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years,” the company said in a statement.
The trial involved 17,604 patients aged 45 years or older with overweight or obesity and established cardiovascular disease with no prior history of diabetes.
Read now: As Ozempic/Wegovy frenzy continues, Morgan Stanley lifts forecasts for weight-loss drugs to $77 billion
“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, executive vice president for development at Novo Nordisk.
The company will apply for regulatory approval for a label indication expansion for semaglutide 2.4 mg in the U.S. and EU in 2023 and will present detailed results at a scientific conference later this year.
See also: EU regulator is reviewing weight-loss drugs Ozempic and Wegovy for risk of suicidal thoughts and self-harm
Wegovy, and a similar product called Ozempic also made by Novo Nordisk, are GLP -1 receptors and are administered as once-a-week injections and used to treat obesity and diabetes. The two resulted in 15.1% weight loss when used in combination with diet and exercise in adults with obesity or overweight and without Type 2 diabetes, according to data released in late June at the American Diabetes Association’s annual scientific conference.
To date, while the drugs help with weight loss, there has been little research into whether they also reduce the risks of developing illnesses associated with obesity beyond diabetes.
Wolfe analysts had put the odds of success at 50/50, but consensus odds were higher and the company itself had exuded a lot of confidence. The 20% reduction in cardio events was greater than expected, said the note, and benefit was seen in all three components, of cardiovascular death, myocardial infarction and stroke.
“This is essentially a best-case scenario,” said the analysts.
The trial matters because “treating obesity with prescription drugs embeds various layers of controversy. Many payers, both U.S. and ex-US, have historically not covered obesity drugs because it was felt to be a “lifestyle” issue. Other lifestyle categories—such as smoking cessation and erectile dysfunction—have had similar payer difficulties, meaning patients often have to pay for their medicines out-of-pocket, if they wanted them.”
The drugs, along with Eli Lilly & Co.’s
LLY,
Mounjaro, have become so popular in the U.S. that supplies have at times run short and the U.S. Food and Drug Administration has been forced to warn patients against using knockoff versions.
Social-media buzz about the drugs has promoted the mistaken perception that the medications are appropriate for a swath of people who may want to shed a few pounds, which has led to negative consequences for some patients, doctors say.
For more, read: The dark side of the weight-loss-drug craze: eating disorders, medication shortages, dangerous knockoffs
The drugs are administered by injection and mimic the effects of GLP-1, a gut hormone that can help control blood-sugar levels and reduce appetite. GLP stands for glucagon-like peptide.
Drug companies, including Pfizer Inc.
PFE,
and Eli Lilly, are now working to develop treatments in the form of pills that could be more convenient alternatives to the injectables.
See now: Weight-loss drugs in development aim to replace injections with pills
Ozempic, Rybelsus and Mounjaro have been approved by the FDA for the treatment of Type 2 diabetes, while Wegovy is approved for people with obesity and for certain people with excess weight combined with weight-related medical problems.
Last year, more than 5 million prescriptions for Ozempic, Mounjaro, Rybelsus or Wegovy were written for weight management, up from 230,000 in 2019, according to data and analytics firm Komodo Health.
See also: Ozempic and other weight-loss drugs boost pharmacy sales at Rite Aid
Obesity drugs could be a $54 billion market by 2030, up from $2.4 billion in 2022, Morgan Stanley said in a report last year. Reports of people who take GLP-1 drugs seeing improvements in addictive behaviors such as smoking and drinking have lately amplified interest in the medications.
Novo Nordisk’s U.S.-listed stock has gained 19% in the year to date, while the S&P 500
SPX
has gained 17.7%.
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