FDA Clears Stronger Wegovy Dose for Enhanced Weight Loss Results

Federal health officials have authorized a more potent version of the popular weight-loss medication Wegovy that could help patients shed additional pounds. The new 7.2-milligram weekly injection nearly triples the strength of the current highest dose and will reach U.S. pharmacies in April.

Federal health authorities gave the green light Thursday to a more powerful formulation of the widely-used weight-loss medication Wegovy, offering hope for enhanced results among patients seeking to shed excess pounds.

The U.S. Food and Drug Administration authorized a 7.2-milligram weekly injection from Denmark-based pharmaceutical company Novo Nordisk. This represents a significant increase from the current maximum strength of 2.4 milligrams per dose.

The enhanced formulation received expedited consideration under the FDA’s accelerated assessment pathway. Officials completed their review within 54 days of accepting the application, according to an agency announcement.

Novo Nordisk plans to make the stronger dose available at American pharmacies beginning in April, with pricing details to be revealed at that time.

European health regulators had previously authorized the higher-strength version in February.

Research participants using the enhanced formulation, branded as Wegovy HD, achieved approximately 19% body weight reduction, equivalent to nearly 47 pounds, compared to roughly 16% weight loss or 39 pounds with the standard dose over a 17-month period.

Scientists developed the stronger version because while the existing 2.4-milligram injection proves effective for many patients, “some individuals do not reach their therapeutic goals” at the current strength, according to findings published in Lancet Diabetes & Endocrinology.

The FDA previously approved an oral Wegovy tablet in December, containing 25 milligrams of the active ingredient semaglutide to ensure proper absorption through the digestive tract.

Dr. Jody Dushay, who specializes in endocrinology and obesity treatment at Harvard Medical School, praised the approval of the stronger injection.

The enhanced dose “may be especially helpful for people” who tolerate the current version well but “have had suboptimal weight loss,” she explained via email. She noted it could also benefit individuals who don’t respond strongly to Eli Lilly’s competing obesity treatment Zepbound.

However, digestive issues including nausea, vomiting and constipation affected more than 70% of patients taking the higher dose, compared to over 60% using the standard strength and approximately 43% receiving inactive treatment, study data revealed.

Additionally, a condition causing uncomfortable skin sensations like burning, stabbing or electric shock-like feelings occurred in roughly 23% of higher-dose patients versus 6% taking the standard dose and under 1% receiving placebo treatment.

Severe complications were documented in nearly 7% of participants using the 7.2-milligram dose, compared to about 11% taking the 2.4-milligram version and roughly 5% receiving inactive treatment.

Dr. Dushay observed that jumping from 2.4 milligrams to 7.4 milligrams represents “quite a big jump,” particularly without an intermediate strength option.

“It will be important to see if in the real world, versus in a clinical study, side effects are any worse,” she cautioned.