DodoFinance Breaking News Made For You!
The FDA has given the green light to Novo Nordisk’s weight-loss drug Wegovy for use in reducing the risk of serious cardiovascular complications in adults with obesity and heart disease. This approval is a major milestone for public health, as weekly injections of Wegovy were found to reduce the risk of heart attack, stroke, and death from cardiovascular causes by 20% in a landmark late-stage trial.
Dr. John Sharretts of the FDA’s Center for Drug Evaluation and Research hailed the approval as a significant advance. He advised patients to use Wegovy in conjunction with a reduced-calorie diet and increased physical activity. This approval could pave the way for broader insurance coverage of the costly drug and similar treatments for obesity, potentially making them more accessible to patients.
Novo Nordisk’s other weight-loss drug, Ozempic, has also been in high demand, leading to shortages due to its effectiveness in aiding weight loss. The company is ramping up its manufacturing capacity to meet the expected demand for Wegovy following the FDA approval. The approval was based on the SELECT trial, which demonstrated Wegovy’s efficacy in reducing the risk of non-fatal heart attacks and strokes, as well as an overall reduction in cardiovascular events within months of starting the drug.
However, the study had limited diversity in participants, with the majority being male and white. Novo Nordisk is anticipated to receive a similar approval for Wegovy in the EU, which could help the company maintain its lead over competing weight-loss drug Zepbound from Eli Lilly, which has yet to demonstrate an effect on cardiovascular outcomes. This approval marks a significant step forward in the fight against obesity-related health issues, offering new hope for patients looking to improve their cardiovascular health.
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