Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration (FDA) for its once-weekly injection Zepbound (tirzepatide). The drug is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity or overweight conditions, including those with at least one comorbidity. The approval is supported by late-stage clinical data demonstrating that the dual GIP/GLP-1 receptor agonist resulted in average body weight losses of 12% and 18% compared to placebo in patients with and without type 2 diabetes (T2D), respectively.
Warnings Accompany Zepbound’s Approval
The FDA’s approval of Zepbound was accompanied by warnings regarding potential side effects, including pancreatitis, gallbladder problems, hypoglycemia, kidney injury, diabetic retinopathy, and suicidal behavior or thinking. The regulator also noted that Lilly’s product has been associated with thyroid C-cell tumors in animal models, although it has not been confirmed whether it causes cancer in humans.
Zepbound’s Transition from Antidiabetic to Weight-Loss Drug
Zepbound’s active ingredient, previously approved in the US as an antidiabetic under the brand name Mounjaro, had been prescribed off-label for weight loss by medical practitioners.- Flcube.com
