Topline
Eli Lilly on Thursday said it is pushing for fast-track approval to greenlight diabetes drug tirzepatide, marketed as Mounjaro, for weight loss after promising clinical trial results, adding a potentially powerful tool to a growing arsenal of obesity drugs that are proving to be both hyped hits and essential medicines tackling a key public health problem.
Lilly said it expects a decision from the FDA by the end of the year.
Key Facts
In a late-stage trial of more than 900 obese or overweight people with type 2 diabetes, Eli Lilly said tirzepatide helped people lose up to 16% of their starting weight over roughly 17 months, an average of 34 pounds.
The findings suggest tirzepatide, given by injection once a week, could be a more powerful weight loss aid than other obesity drugs on the market, notably Novo Nordisk’s Ozempic and Wegovy.
The “degree” of weight loss in the trial is greater than that from other late-stage trials for overweight or obesity and type 2 diabetes, explained Jeff Emmick, senior vice president for product development at Lilly.
The findings, which have not been published in full or subjected to external peer review, add to previous research on overweight or obese people without diabetes, which showed tirzepatide helped people lose more than 20% of their weight.
Lilly said it plans to finalize its submission with the Food and Drug Administration for a fast-track approval to sell tirzepatide to help overweight or obese people without diabetes manage their weight.
Lilly said it expects a decision from the FDA by the end of the year.
News Peg
The FDA granted Lilly a fast-track designation for weight loss in October 2022, just months after it was authorized for use in type 2 diabetics. It is one of several diabetes drugs to reach market in recent months that have also shown promise—and success, including among celebrities like Elon Musk—as weight loss aids. The drugs, including tirzepatide, are often prescribed off-label, meaning for purposes they have not been explicitly approved for. While the drugs have become viral hits for those looking to lose weight and big sellers for the pharma firms making them, they are also important public health tools. Obesity is a major and growing public health issue and contributes towards a variety of conditions like diabetes, heart disease and some cancer and the World Health Organization is considering including some on its essential medicines list. While many medical professionals and researchers have celebrated the arrival of a pharmacological means to lose weight, others argue the money spent on the drugs—particularly for publicly funded care—would be better spent addressing root causes of obesity or that they needlessly stigmatize obesity and frame it as an illness in need of treatment.
Big Number
650 million. That’s how many adults around the world were considered to be obese as of 2016, according to the WHO. Another 1.25 billion adults were considered overweight at that time, the agency said. The figures mean nearly 4 out of every 10 adults were overweight and 13% were obese.
Further Reading
Diabetes Drug Mounjaro Expected To Be Approved For Weight Loss Soon: What To Know And How It Compares To Similar Drugs (Forbes)
‘Breakthrough’ Obesity Drugs Are Effective but Raise Questions (Scientific American)
What To Know About Ozempic: The Diabetes Drug Becomes A Viral Weight Loss Hit (Elon Musk Boasts Using It) Creating A Shortage (Forbes)
Source: https://www.forbes.com/sites/roberthart/2023/04/27/eli-lilly-pushes-for-fast-track-approval-of-mounjaro-as-weight-loss-drug/