The FDA approved a higher-dose Wegovy shot for weight loss on Thursday, opening a new option for patients who do not reach goals on smaller amounts. The agency approved the 7.2-milligram dose of Novo Nordisk’s semaglutide as a weekly injection, replacing the prior highest approved strength of 2.4 milligrams, according to the FDA.
The FDA said the higher-dose decision used its ultra-fast drug review program. The agency also said the approval came 54 days after the FDA approved Novo Nordisk’s request for the review.
Novo Nordisk said the higher-dose version, branded Wegovy HD, will be available in April at pharmacies in the United States, and it said the price would be announced then. The company also said European drug regulators approved the higher-dose version in February.
The approval is tied to study results that compared the higher dose with the 2.4-milligram weekly dose and placebo over nearly 17 months. In that trial, Wegovy HD helped participants lose about 19% of their body weight, or almost 47 pounds, compared with about 16% of body weight, or about 39 pounds, with the lower dose, the article said. The FDA approval also reflected that the higher dose was developed because some people do not reach “their therapeutic goals” on the 2.4-milligram dose, using results published last year in The Lancet Diabetes & Endocrinology.
Even as the higher dose produced greater weight loss in the study, the results also showed more frequent side effects for some participants. The article said nausea, vomiting and constipation were reported in more than 70% of those who took the 7.2-milligram dose, compared with more than 60% for the lower dose and about 43% in those who received a dummy medication. It added that a condition involving unpleasant skin sensations—described as burning, stabbing, or an “electrical shock” feeling—occurred in about 23% of people on the higher dose versus 6% on the lower dose and less than 1% with placebo.
The study also reported serious adverse events for a share of participants at each dose level. The article said serious adverse events were reported in nearly 7% of those taking the 7.2-milligram dose, versus about 11% taking the 2.4-milligram dose and about 5% with placebo. In a note shared by the article, Dr. Jody Dushay, an endocrinologist and obesity expert at Harvard Medical School, said the jump in highest dose from 2.4 milligrams to 7.2 milligrams was “quite a big jump,” particularly without an intermediate dose.
Dushay said it will be important to see how side effects compare outside clinical trials. She said “It will be important to see if in the real world, versus in a clinical study, side effects are any worse.” In the same email, Dushay welcomed the approval, adding it “may be especially helpful for people” who are tolerating the lower-dose version but “have had suboptimal weight loss,” and she said it could also help people who do not have a robust response to the highest dose of Eli Lilly’s obesity drug Zepbound.
The approval came as regulators are also expanding obesity-drug options beyond injections. In December, the FDA approved an oral Wegovy pill, which the article said contains 25 milligrams of semaglutide—described as the amount needed for absorption through the digestive system.