The U.S. Food and Drug Administration approved the weight-loss drug Wegovy as a treatment to reduce cardiovascular risk in adults who are overweight, the first approval of its kind that could dramatically expand the already huge market for the drug.

Wegovy, which has the same active ingredient as diabetes drug Ozempic, already had FDA approval to treat patients who are obese or overweight. It has become a cultural sensation and a blockbuster, bringing in billions of dollars in revenue for its manufacturer, Novo Nordisk.

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” John Sharretts, a director in the FDA’s Center for Drug Evaluation and Research, said in a statement Friday.

“We recognize how important this moment is for the millions of people who live with excess weight or obesity and known heart disease, and we will continue to advance options that put their needs first,” Doug Langa, head of Novo Nordisk’s North American operations, said in a statement.

The FDA’s expansion of Wegovy’s regulatory label comes after a closely watched clinical trial last year found that the drug dramatically reduced the risk of heart problems for overweight people. In a five-year study of more than 17,600 patients, Wegovy cut the risk of strokes, heart attacks and other cardiovascular problems by 20 percent among overweight adults with a history of heart disease. Expanding Wegovy’s regulatory label could also entice more insurers to cover the pricey drug, according to researchers and Wall Street analysts.

“The result will pressure insurers and the federal government to cover this medication,” said Harlan Krumholz, a cardiologist at the Yale School of Medicine. “It will be increasingly difficult to deny people access to these medications, as this is not about appearance but concerns health.”

Wegovy, whose active ingredient is semaglutide, works by mimicking a naturally occurring hormone called glucagon-like peptide 1 (GLP-1). It slows the emptying of the stomach and sends a signal of fullness to the brain.

Some financial analysts say GLP-1 drugs, as they’re sometimes called, including Eli Lilly’s tirzepatide-based products Mounjaro and Zepbound, could become the biggest-selling class of drugs ever. In a December report, Goldman Sachs compared Novo Nordisk and Eli Lilly’s innovations with Amazon and Apple, saying they “have the opportunity to expand into categories far beyond what most investors are currently contemplating.”

But their dominance is far from assured, as competitors large and small are creating their own weight-loss drugs that rival the market-leading drugs. In addition, the high cost of the drugs – the list price for a month’s supply of Wegovy costs more than $1,300 – means some employers and insurance plans have been reluctant to cover the medications. Undesirable side effects, including nausea and vomiting, can also limit how long patients are willing to take the weekly injectable drug.

Demand for Wegovy has been so intense that Novo Nordisk has struggled to churn out enough, leading the FDA to declare the drug in shortage beginning in March 2022. Novo and Lilly are racing to secure enough manufacturing power to keep up with the growing demands for their marquee products.

Denmark-based Novo said in January that it had begun boosting supplies of Wegovy in the United States, after curtailing starting doses last year to ensure there would be enough for existing patients. Then in February, Novo’s controlling shareholder acquired Catalent, a manufacturer based in New Jersey, an unusual move that would give the drugmaker three new manufacturing plants.

On the front lines of battling obesity, some doctors caution the FDA’s decision does not mean insurers will quickly embrace paying for the drugs. At the Stanford Lifestyle and Weight Management Center at Stanford University, insurers routinely deny patients who qualify for the weight-loss drugs, often for opaque reasons, said Dan Azagury, the center’s medical director.

He said he doesn’t expect that to change, but the FDA’s decision on Wegovy “gives physicians one more leg to stand on when they are trying to justify to insurance companies that this treatment is the right treatment.”

Dana P. Goldman, an economist at the University of Southern California, said insurers will eventually be able to negotiate lower prices for GLP-1 drugs. “We are going to see a very steep discount on these products in the next couple years,” he said, adding, “The challenge will be scaling up” production.

Copy the Story Link

« Previous

Future of emergency services in central Maine up for debate as Delta Ambulance raises rates

Next »

New state law makes medical bills in Maine more transparent