WHO Panel to Review Obesity Drug Liraglutide for Essential Medicines List
核心洞察
The WHO will review a request to add liraglutide, the active ingredient in Novo Nordisk's Saxenda, to its essential medicines list for the first time next month.
The proposal was submitted by US researchers who argue that obesity drugs should be included given the global burden of weight-related diseases in low- and middle-income countries.
Over 650 million adults worldwide are obese with 70% living in low- and middle-income countries, representing a tripling of obesity rates since 1975.
Drugs that combat obesity could for the first time be included on the World Health Organization's "essential medicines list," used to guide government purchasing decisions in low- and middle-income countries. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September.
The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. It covers the active ingredient liraglutide in Novo Nordisk's obesity drug Saxenda, which will come off patent soon, allowing for cheaper generic versions.
Global Obesity Crisis Drives Policy Consideration
Over 650 million adults worldwide are obese, more than triple the rate in 1975, and roughly another 1.3 billion are overweight, according to the WHO. The majority – 70 percent – live in low- and middle-income countries.
"At present, there are no medications included in the (list) that specifically target weight loss for the ongoing global burden of obesity," wrote US researcher Dr. Sanjana Garimella from Yale New Haven Health, Dr. Sandeep Kishore from the University of California, San Francisco, and colleagues to the WHO in requesting the addition.
The researchers argue that while the list includes mineral supplements for nutritional deficiencies, the lack of weight-loss treatments represents a "discrepancy" in global health equity, given the increasing number of deaths in poorer nations hastened by weight-related illness, including heart disease and diabetes.
Treatment Efficacy and Cost Considerations
Saxenda, a once-daily injection, has been shown to help people reduce 5 percent to 10 percent of their body weight, at $450 per month in the US and $150 per month in Europe. People using Wegovy, a weekly injection that costs more than $1,300 a month in the US, have lost up to 15 percent of their weight.
Both drugs belong to a class of medicines called GLP-1 receptor agonists, which have been used for years to treat diabetes. They affect hunger signals to the brain and slow the rate at which a person's stomach empties, making them feel fuller longer. Eli Lilly and Co has a similar diabetes drug nearing approval for weight loss.
Potential Impact and Precedent
Including obesity drugs among the WHO's essential medicines could have great significance for populations in low- and middle-income countries. Experts say that adding HIV drugs to the list in 2002 helped to make them much more widely available to AIDS patients in poorer countries.
A decision by the WHO to include Saxenda and eventual generics on the list would mark a new approach to global obesity by the health agency. It could also pave the way for a newer, more powerful treatment from Novo Nordisk called Wegovy to be recommended for low- and middle-income countries in future.
The Danish drugmaker said in a statement it was not involved in the application to consider liraglutide for inclusion on the WHO list, adding, "we welcome the WHO review and look forward to the readout and decision."
Expert Concerns and Limitations
However, some public health experts warn against introducing such medicines too broadly as a solution to a complex condition that is still not completely understood. For both Saxenda and Wegovy, there is a lack of long-term safety and effectiveness data for obesity. Studies suggest people will likely have to take the drugs for the rest of their lives to keep the weight off.
"Obesity is an increasingly important health problem in many countries," said a WHO spokesman. "Medicines for the treatment of obesity are only one aspect of management, of course, and prevention is also crucial."
Professor Zulfiqar Bhutta, an obesity expert at the University of Toronto, said the phenomenon of obesity in low- and middle-income countries must be better understood to help determine the best course of action. "Preventive strategies and sustained efforts at education, gender-focused interventions, must take precedence over the use of obesity drugs, which require a lot more research for safety and effectiveness," he said.
The WHO said the expert panel would consider the evidence for liraglutide over the coming months. They may also seek a broader evaluation of other types of weight-loss treatments in the future. The panel could reject the request or wait for more evidence.