Novo Nordisk, the Danish drug maker whose fortunes have soared on the popularity of its GLP-1 agonist drugs, scored a long-sought label expansion for its weight-loss drug Wegovy on Friday, with the Food and Drug Administration approving it to reduce the risk of major cardiovascular events in adults who are obese or overweight and have established cardiovascular disease.
The approval is based on a nearly five-year-long study in which once-weekly injections of Wegovy were shown to reduce the overall risk of major adverse cardiac events—including stroke, heart attack, and death—by 20% compared to a placebo. (Wegovy reduced the risk of cardiovascular death by 15%, and death from any cause by 19%.) The label expansion is expected to expand insurance coverage for the drug, which brought in sales of about $4.5 billion last year despite persistent supply shortages.
First approved for weight loss in June 2021, Wegovy contains the same active ingredient as Ozempic—an engineered peptide called semaglutide—but at a higher dosage. In clinical trials, the mean (average) weight loss in patients taking Wegovy was nearly 15%. But the drug’s high retail price—typically more than $1,000 per month before insurance or manufacturer rebates—and the reluctance of many health insurers and employer health plans to cover the drugs for weight loss, has made them inaccessible for many, and driven a thriving gray market for knockoff drugs.
The expanded indication for cardiovascular disease could be a game changer, though. While the desire to lose weight may be seen by some as mere vanity, it is hard to argue against covering the cost of a drug that significantly cuts the risk of heart attack, stroke, and premature death. Heart disease is the leading cause of death in the U.S. Many analysts estimate the global market for cardiovascular drugs to approach or surpass $200 billion by 2032.
The new indication puts Novo Nordisk ahead of its main rival, Eli Lilly, whose weight-loss drug Zepbound—which showed slightly better efficacy than Wegovy in trials—got FDA approval in November 2023. But the company will have to get on top of its supply chain issues. Last year, Novo had to temporarily halt new prescriptions for Wegovy as it struggled to keep up with demand. Whether the company can cope with a new surge in prescriptions will depend on how quickly it can ramp up manufacturing. Novo announced multibillion-dollar investments last fall to upgrade manufacturing sites in Denmark and France; and in February, its parent company, Novo Holdings, paid $16.5 million to acquire manufacturer Catalent, which has been the main contractor filling and packaging syringes and injection pens for Wegovy.
Novo Nordisk is pursuing additional indications beyond heart disease—including in liver and kidney disease, Alzheimer’s disease, and osteoarthritis. It’s also working on its next anti-obesity blockbuster. The company recently launched a phase 3 trial of a combination drug called CagriSema, pitting it against Lilly’s Zepbound. And on Thursday last week, the day before the FDA announcement, Novo shared results of a phase 1 trial of an experimental weight-loss drug called Amycretin.
In the study, an oral formulation of CagriSema was associated with a mean change in body weight of 13.1% at 12 weeks—more than twice the weight loss experienced with Wegovy in the same amount of time. The data sent Novo’s stock up more than 8% for the day. The company expects to be able to launch the drug this decade—and CEO Lars Fruergaard Jørgensen has been good to his word so far, sticking new drug approvals as promised and earning his 13% raise last year.
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