The Food and Drug Administration approved a higher-dose version of a popular class of obesity drugs on Thursday, the latest expansion in a rapidly growing market for weight-loss treatments.
The newly authorized dose of Novo Nordisk’s Wegovy increases the maximum weekly injection from 2.4 milligrams to 7.2 milligrams, offering patients a stronger option if they have not achieved the desired results with existing therapies.
Federal regulators cleared the higher dose under an expedited review program, with approval granted in just 54 days, the agency said in a release. The Wegovy pill, rather than injections, was approved in December.
FDA Commissioner Martin Makary said the fast-track approval reflects the agency’s goal of combating obesity in the United States.
“The new FDA is moving with unprecedented efficiency on products that advance national priorities,” Makary said. “Today’s approval is another demonstration of what the FDA can accomplish when we try bold new things.”
Clinical trial data showed that patients taking higher doses lost significantly more weight than those on the standard regimen, while maintaining a safety profile similar to that of other semaglutides. Participants lost roughly 19% to 20% of their body weight on average over more than a year of treatment, compared to about 16% on the lower dose.
GLP-1 drugs, including Wegovy and similar medications, mimic hormones that regulate appetite and blood sugar, helping patients feel full and eat less.
While experts say the new dose could benefit patients who need additional weight loss, they caution that higher doses may increase side effects. Trial participants reported more frequent side effects, such as nausea, vomiting, and gastrointestinal discomfort, with some experiencing more adverse events.
They are typically prescribed alongside diet and exercise and have surged in popularity in recent years, fueled in part by high-profile public figures, a trend that has also sparked debate over access, cost, and cosmetic use.
Thursday’s approval also intensifies competition between Novo Nordisk and rival Eli Lilly, whose own obesity drugs have shown similar or greater weight loss results in trials.
The higher-dose Wegovy injection is expected to become available in U.S. pharmacies as early as next month, offering doctors another tool as they confront rising rates of obesity and related chronic illness, such as Type 2 diabetes.
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The higher-dose approval comes as demand for these medications continues to climb following earlier shortages driven by surging prescriptions.
The FDA has also taken steps to crack down on unapproved versions of GLP-1 drugs marketed to consumers, citing safety concerns. In February, the agency said that non-FDA-approved weight-loss drugs, including those marketed by telehealth company Him & Hers, do not deliver clinically proven results.
