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Mar 13

Wegovy Approved By FDA to Reduce Heart Attack Risk – The New York Times

Lose Weight Comments Off on Wegovy Approved By FDA to Reduce Heart Attack Risk – The New York Times

Wegovy, the blockbuster weight loss drug, is now approved for a new use: reducing the risk of heart attacks, strokes and cardiovascular-related death in adults who have heart disease and are overweight or have obesity.

The new indication, which the Food and Drug Administration announced on Friday, will pave the way for even more patients to use the sought-after medication and could potentially broaden insurance coverage. The drugs maker, Novo Nordisk, said it had also filed for an expanded label in the European Union.

The F.D.A. approval was based on the results of a large study of over 17,000 adults ages 45 and older. Researchers either gave participants shots of Wegovy or a placebo and followed them for several years. Among those who received placebo shots, 8 percent had a heart attack, stroke or died from a cardiovascular event, compared with 6.5 percent of participants who took Wegovy.

While its not clear whether the effect of the drug is purely from weight loss, or whether the drug has other heart benefits, the data shows that when you treat obesity seriously in people who have a high burden of disease, you can get really good outcomes, said Dr. Melanie Jay, director of the N.Y.U. Langone Comprehensive Program on Obesity.

The new indication comes at a challenging moment for the relatively new class of drugs that includes Wegovy and Ozempic. The medications are highly effective, but costly: Wegovy has a list price of over $1,300 for about a months supply. And doctors typically say patients may need to take these drugs for the rest of their lives. Those cost considerations have led some employers and health plans to stop covering the medications, or to limit access or cap spending amid soaring demand.

The updated label will likely deepen the pressure on payers and employers to cover the drugs. Many of the patients who could qualify for Wegovy under the new indication may be on Medicare, said Dr. Andrew Kraftson, clinical associate professor in the division of metabolism, endocrinology and diabetes at Michigan Medicine.

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Wegovy Approved By FDA to Reduce Heart Attack Risk - The New York Times

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