Topline
The Food and Drug Administration on Wednesday approved drugmaker Eli Lilly’s Mounjaro diabetes drug as a weight loss treatment under the name Zepbound for adults who are obese or are overweight with at least one weight-related condition, such as high blood pressure—and experts say it could eventually be the best-selling drug of all time.
Eli Lilly’s Zepbound helped users lose up to 22.5% of their weight in clinical trials. (Photo by … [+]
Key Facts
Zepbound, generically called tirzepatide, is a drug that helps the body reduce appetite and food intake, and is injected once weekly, according to the FDA.
In clinical trials, a weekly 15 milligram dose of tirzepatide was shown to reduce weight by 22.5%—or an average of 52 pounds for subjects with a median weight of 231 pounds, in 72 weeks.
Eli Lilly said Zepbound is expected to be available in the U.S. by the end of the year and has a list price of $1,060 for a 1-month prescription, and the drugmaker is implementing a commercial savings card program to help people afford the drug if it isn’t covered by health insurance.
Zepbound should be used alongside a reduced-calorie diet and increased physical activity, the FDA and Eli Lilly said, and can cause side effects such as nausea, abdominal discomfort and pain and hair loss.
The FDA has only approved two other similar drugs—Wegovy and Saxenda—for weight loss, while Ozempic, commonly prescribed by doctors to treat obesity, has not been approved for that use.
Eli Lilly’s stock rose over 3% on the news of the FDA’s approval.
Key Background
Tirzepatide, the active ingredient in Zepbound, has already been approved by the FDA and marketed as Mounjaro, a weekly diabetes drug injection that controls blood sugar. Zepbound is a GLP-1 (glucagon-like peptide-1) receptor agonist that activates hormone receptors that reduce appetite and food intake, and mimics the GIP (glucose-dependent insulinotropic polypeptide) hormone that helps release insulin, which controls blood sugar levels after eating. Around 70% of adults in America are obese or overweight, the FDA said, noting many overweight adults have a weight-related condition such as high blood pressure or Type 2 diabetes. Using diet and exercise to reduce five to 10% of body weight can lead to a reduced risk of cardiovascular disease in obese or overweight adults, the FDA said. Zepbound joins the ranks of other popular weight loss drugs such as Mounjaro and Novo Nordisk’s Ozempic and Wegovy, which are facing shortages.
Surprising Fact
Zepbound was found to cause thyroid C-cell tumors in rats, but it is not known if the drug causes tumors, including cancers that form inside the thyroid gland, in humans, the FDA said.
Further Reading
Diabetes Drug Mounjaro Expected To Be Approved For Weight Loss Soon: What To Know And How It Compares To Similar Drugs (Forbes)
A new weight loss drug could become the best-selling drug of all time. Who can afford it? (NBC News)
Source: https://www.forbes.com/sites/britneynguyen/2023/11/08/fda-approves-diabetes-drug-mounjaro-for-weight-loss-under-brand-name-zepbound/