Eli Lilly weight loss drug Zepbound approved by the FDA

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Eli Lilly weight loss drug Zepbound approved by the FDA

Move over, Ozempic — there’s a new drug in town.

Eli Lilly’s Zepbound, with the active ingredient tirzepatide, has been approved by the Food and Drug Administration for use by obese or overweight adults who have at least one weight-related health complication, such as Type 2 diabetes, high blood pressure or high cholesterol.

Tirzepatide, sold as Mounjaro, has already been approved to treat Type 2 diabetes since May 2022, but now, patients can be prescribed the drug for chronic weight management.

“Obesity and overweight are serious conditions that can be linked to several leading causes of death such as heart disease, stroke and diabetes,” Dr John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity for the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Given the increasing rates of obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

Zepbound is expected to be available to Americans by the end of this year.AP

About 70% of Americans are overweight or obese, according to the FDA, and an alarming report published by the World Obesity Federation this year projects that more than half of the world’s population could be overweight or obese by 2035.

However, the FDA reports that losing just 5% to 10% of total body weight can reduce the risk of developing heart disease as a result – a signal weight management drug, which can help people lose stubborn pounds when diet and exercise alone have failed.

“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice — something people must manage on their own,” said Dr. Leonard Glass, senior vice president of global medical affairs at Lilly Diabetes and Obesity, in a statement.

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“Lilly aims to dispel misconceptions about this disease and change the way it can be managed.”

Tirzepatide, the active ingredient in Zepbound, is already approved to treat Type 2 diabetes under the name Mounjaro.REUTERS

Zepbound, which was approved on Wednesday, has been shown to be an effective chronic weight management drug in combination with lifestyle changes such as diet and exercise by activating receptors for two hormones – glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide – to suppress appetite, thereby restricting food intake.

Side effects of weekly injections include nausea, vomiting, abdominal discomfort or pain, fatigue, diarrhea, constipation, belching, hair loss, acid reflux and allergic reactions.

In tests, the drug caused thyroid C-cell tumors in mice, although it is not known whether Zepbound can cause the same cancer in humans.

“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice — something people should manage on their own,” Glass.AP said.

According to the drug’s manufacturer, Zepbound is expected to be available to Americans by the end of the year with a list price of about $1,059, which Eli Lilly estimates is 20% less than rival semaglutide, otherwise known as Novo Nordisk’s Ozempic or Wegovy, which costs a staggering $1,300.

But demand for the weight-loss cure-all has soared, leading to a market of dangerous fakes, which have left consumers desperate in hospitals.

And, despite the push for more drug access, “it’s not improving or changing insurance coverage,” which has been limited, explained Dr. Angela Fitch, chief medical officer at weight-care company Knownwell.

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“It remains a problem that obesity is treated as an undesirable condition rather than a standard benefit, despite the fact that it is a chronic condition,” he told The Post in a statement.

“We hope that with continued advocacy, advances in science and data, we will continue to see increased access to these life-changing medicines.”

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Source: thtrangdai.edu.vn/en/