The FDA Approval of a New Treatment for Obesity in the U.S., based on Glucagon-like Peptide-1
The FDA gave approval to a new drug called Zepbound for the treatment of obese adults.
The Lilly drug works by acting on two hormone receptors in the brain, including one called GLP-1, short for glucagon-like peptide-1 – that regulate appetite and metabolism.
Nausea, the most common side effects of the drug are listed. The drug also caused thyroid tumors in rats, though the FDA said it’s not known if Zepbound causes the same kind of tumors in humans.
In announcing the approval, the FDA cited the growing public health concern over excess weight. The FDA’s Center for Drug Evaluation and Research said that today’s approval addresses an unmet medical need due to the increasing rates of both excess weight and overweight in the US. About 70% of adult Americans have obesity or overweight, the FDA noted.
“New treatment options bring hope to the many people with obesity who struggle with this disease,” said Joe Nadglowski, president and CEO of the Obesity Action Coalition, in a statement released by Lilly. He noted numerous life-threatening diseases — from heart attacks and strokes to diabetes — that are linked to obesity.
Improving the Affordableness of Wegovy and Ozempic to Weight-Loss Treatments for Medicare enrollees
The actual amount patients would pay would depend on their insurance coverage and potential discounts. Insurance coverage for Wegovy, for example, varies widely by provider.
Lilly said there may be a way to pay as low as $25 for a prescription for a one-month or three-month period.
Medicare doesn’t pay for weight-loss drugs. However, Congress is considering measures that would expand insurance access to cover treatments for obesity, including some of the new medications, for Medicare enrollees.
Zepbound and Mounjaro are similar to the better-known Wegovy and Ozempic, which are both manufactured by Danish company Novo Nordisk. All of these drugs mimic a naturally occurring hormone in the body called GLP-1. Produced in the gut, GLP-1 lowers blood sugar, slows the emptying of the stomach, and regulates appetite. Zepbound and Mounjaro also act on a similar hormone called GIP to reduce food intake.
GLP-1 drugs were developed to treat diabetes but are now being used to lose weight. Wegovy can be prescribed for weight management, but it can also be prescribed off-label for diabetes. 70% of Americans are either overweight or obese and many of them have a weight related health condition.
Thanks to rising demand for these drugs, Ozempic and Wegovy have been on the FDA’s drug shortage list since March 2022. With demand outstripping production, Novo Nordisk has tried to limit the number of new people who can start taking Wegovy. The drug comes in preloaded injector pens containing different doses, and patients must start out with a low-dose pen before gradually stepping up to higher doses. The drugmaker is restricting supply of those low-dose injections so it can focus on serving current patients as it works to boost production capacity.
Drugmakers are working on pill versions of GLP-1 drugs, which could make them more attractive to patients. With new data expected to be unveiled at the American Heart Association meeting on the cardiovascular benefits of these drugs, demand could surge even more.