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. But until now, Wegovy — also semaglutide but with a higher maximum dose than Ozempic — was the only approved drug that could safely elicit substantial weight loss in people with obesity alone.
Side effects with Zepbound, similar to those with Wegovy, Ozempic and Mounjaro, are mostly gastrointestinal, like nausea and diarrhea. Most patients tolerated or overcame them.
In a news release, Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity in the F.D.A.’s Center for Drug Evaluation and Research, said, “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
Susan Yanovski, co-director of the office of obesity research at the National Institute of Diabetes and Digestive and Kidney Diseases, said, “Just a few years ago it would be difficult to imagine two medications like semaglutide and tirzepatide that lead to weight loss that previously was only seen when people had bariatric surgery,” referring to a surgical treatment that is a proven effective treatment for obesity.
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.
“You’d want the price competition to come sooner rather than later,” said Craig Garthwaite, a health care economist at Northwestern University. Once people start taking one of these drugs, he said, “they get locked in.” They resist switching even if a competing drug costs less.
In a packed room at a meeting of the American Diabetes Association last year, the study’s principal investigator, Dr. Ania Jastreboff of Yale, revealed the results. More than half the patients receiving the highest dose lost at least 20 percent of their body weight.No drug has ever before shown such a profound weight loss.
This content was originally published here.