Federal regulators on Thursday approved a new higher-dose version of the blockbuster obesity drug Wegovy that may help users lose more weight and keep it off.
The U.S. Food and Drug Administration approved a 7.2-milligram dose of Danish drugmaker Novo Nordisk's semaglutide. Previously, the highest approved dose of the drug, taken as a weekly shot, was 2.4 milligrams.
The new dose received accelerated review through the FDA's ultra-fast drug review program.
The approval was granted 54 days after the request for review was approved, the agency said in a statement.
The new dosage will be available in April at pharmacies in the U.S., with a price to be announced then, according to the company.
European drug regulators approved the higher-dose version of Wegovy in February.
Called Wegovy HD, the higher-dose drug helped participants in a study lose about 19% of their body weight, or almost 47 pounds, versus about 16% of body weight, or 39 pounds with the lower dose over almost 17 months.
The higher dose was developed because while the 2.4-milligram shot is effective, “some individuals do not reach their therapeutic goals” at that dose, according to results published last year in the medical journal Lancet Diabetes & Endocrinology.
The FDA in December approved an oral Wegovy pill. It contains 25 milligrams of semaglutide, the amount needed to ensure the drug is absorbed via the digestive system.
Dr. Jody Dushay, an endocrinologist and obesity expert at Harvard Medical School, welcomed the approval of the higher-dose shot.
It “may be especially helpful for people” who are tolerating the lower-dose version, but "have had suboptimal weight loss,” she said in an email. It also could be helpful for people who don't have a robust response to the highest dose of Eli Lilly's obesity drug Zepbound, she added.
Still, side effects such as nausea, vomiting and constipation were reported in more than 70% of those who took the higher dose of Wegovy, compared to more than 60% taking the lower dose and about 43% taking a dummy medication, the study showed.
And a condition in which people experience unpleasant skin sensations such as burning, stabbing or a feeling like an electrical shock occurred in about 23% of those taking the higher dose of Wegovy versus 6% of those taking the lower dose and less than 1% in people who received a placebo.
Serious adverse events were reported in nearly 7% of those taking the 7.2-milligram dose of the drug in the study, versus about 11% of those taking the 2.4-milligram dose and about 5% of those who received a placebo.
Increasing the highest dose of Wegovy from 2.4 milligrams to 7.4 milligrams is “quite a big jump,” especially without an intermediate dose, Dushay noted.
“It will be important to see if in the real world, versus in a clinical study, side effects are any worse,” she said.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
