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.
The FDA’s expansion of Wegovy’s regulatory label comes after a closely watched clinical trial last year found that the drugthe 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.
“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 .
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.
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