However, medics should be  cautious while using the drug, say officials

In a significant development, the United States Food and Drug Administration (FDA) announced on recently that it has approved Eli-Lilly’s tirzepatide injection, marketed as Zepbound, a novel injectable diabetes drug designed for weight loss in overweight and obese adults. 

The formulation shares its active ingredient, tirzepatide, with the diabetes medication Mounjaro. Emphasising on the gravity of the situation Dr John Sharretts, Director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said, “Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes.”

The FDA's approval of Zepbound parallels its earlier endorsement of Wegovy for obesity treatment, a drug with the same active ingredient as the diabetes medication Ozempic. FDA eastimates that approximately 7 in 10 American adults are overweight or obese, with many facing weight-related health risks such as high blood pressure, type 2 diabetes, or elevated cholesterol levels. 

Recognising the urgent medical need, Dr Sharretts noted, “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

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The formulation operates by activating hormone receptors to reduce appetite and food intake, and is injected weekly. The FDA approval came on the basis of two 72-week clinical trials involving over 2,500 patients receiving varying Zepbound doses and nearly 1,000 patients receiving weekly placebo injections. Results demonstrated a significant weight reduction in patients across all Zepbound dose levels compared to the placebo group, with a higher proportion achieving at least a 5% weight reduction.

In one trial involving non-diabetic adults, the highest approved dose of Zepbound resulted in an average weight loss of 18%, compared to the placebo group. In another trial with adults having type 2 diabetes, the drug facilitated an average weight loss of 12% compared to the placebo group.

Commenting on formulation’s efficacy, Diana Thiara, Medical Director of the University of California, San Francisco's Weight Management Program, said, “The high rates of weight loss are really powerful,” likening the effects to those seen with weight-loss surgeries. 

However, Thiara cautioned against using Zepbound for short-term weight loss without focusing on healthy eating and lifestyle changes.

It may be worthwile to note that while Zepbound demonstrates promising results, it is not without side effects. Patients may experience nausea, diarrhoea, vomiting, constipation, stomach pain, fatigue, allergic reactions, burping, hair loss, and acid reflux. 

Additionally, regulators are particularly vigilant regarding potential links between Zepbound and thyroid cancer, given its association with thyroid C-cell tumors in rats. The FDA emphasised that Zepbound should not be used in patients with a family history of medullary thyroid cancer or in those with Multiple Endocrine Neoplasia syndrome type 2.

Notably, Zepbound's approval underwent fast-tracking and received priority review by the FDA.