The FDA approved a new 7.2-milligram dose of Novo Nordisk's obesity drug Wegovy on Thursday, more than tripling the previous maximum dose of 2.4 milligrams. The higher-dose version, called Wegovy HD, received accelerated review and was approved 54 days after the review request. The drug will be available at U.S. pharmacies in April, with pricing to be announced.
The higher dose was developed to help patients who don't achieve their weight loss goals with the standard dose. European regulators previously approved the higher-dose version in February. Obesity experts say the new option could benefit patients who tolerate the current dose well but haven't seen optimal results.
In clinical trials lasting almost 17 months, participants taking the 7.2-milligram dose lost approximately 19% of their body weight, or about 47 pounds, compared to 16% body weight loss, or 39 pounds, with the lower dose. However, side effects including nausea, vomiting, and constipation were reported in more than 70% of patients taking the higher dose, compared to more than 60% on the standard dose.
The approval expands treatment options for obesity as demand for GLP-1 medications continues to surge. Dr. Jody Dushay from Harvard Medical School noted the higher dose may also help patients who don't respond well to competing obesity drugs like Eli Lilly's Zepbound. The FDA previously approved an oral version of Wegovy in December containing 25 milligrams of the active ingredient semaglutide.