The Food and Drug Administration on Wednesday approved an obesity drug from the company Eli Lilly that will be a direct competitor to the wildly popular Wegovy. The drug is called tirzepatide and will be sold under the name Zepbound. It joins a class of new medications that are transforming obesity, a condition that affects 100 million American adults and is linked to a spectrum of diseases including diabetes, heart disease, sleep apnea, liver disease, kidney disease and joint pain.
Patients who used tirzepatide lost an average of 18 percent of their body weight, according to the F.D.A., when it was taken at its highest dose in a drug That’s compared with Wegovy, manufactured by Novo Nordisk, which produced an average 15 percent weight loss.
The F.D.A. approved Zepbound for people with obesity and for those who are overweight and have at least one obesity-related condition. Tirzepatide is already approved for diabetes under the brand name Mounjaro where it competes with Novo Nordisk’s diabetes drug semaglutide, known better as Ozempic. The approval comes at a time when Novo Nordisk is unable to produce enough Wegovy to satisfy the huge demand for the drug. Tirzepatide, which patients take by a self-administered injection once a week, as they do with Wegovy, could ease those shortages.
Development of Zepbound began in 2017 with a small study involving 300 people with type 2 diabetes. After 3 months, many lost at least 13 percent of their body weight. Eli Lilly presented the data at a diabetes meeting in Germany. Some in the audience gasped. Then came a large 72-week study sponsored by Eli Lilly of tirzepatide in 2,539 people with obesity.
The company’s scientists tested the drug in healthy volunteers. Even though they did not have obesity, the people lost weight. They decided to speed development with an approach known as “investing at risk” in which they do not wait for each stage of testing to be completed before starting the next, and in which they start building manufacturing capability before studies are completed. The result was a pace that was a record for the company — six years from the first dose in human volunteers to F.D.A. approval.
