Saxenda, a Promising Weight Loss Medication, May Be Added to WHO List, Potentially Lowering Costs Globally

Next month, the advisors of the World Health Organization (WHO) are scheduled to convene a meeting to consider the inclusion of liraglutide on its Essential Medicines List. If approved, this could enable the drug to be easily accessible in all hospital systems globally at an affordable price, and could also pave the way for other weight-loss medications to follow suit.

Liraglutide is classified as a glucagon-like peptide-1 (GLP-1) receptor agonist and is administered through injections. Initially designed for regulating blood sugar levels in individuals with type 2 diabetes, the medication was also granted approval for weight management in overweight and obese individuals when used in conjunction with diet and exercise. The Food and Drug Administration (FDA) first authorized the drug for weight management in adults in 2014, followed by approval for weight management in children in 2020.

Saxenda, which is the brand name for liraglutide, can have varying costs depending on several factors, including the treatment plan, pharmacy, and insurance coverage. According to Novo Nordisk, the pharmaceutical company that produces the medication, the monthly list price of Saxenda is $1,349.02.

The addition of liraglutide to the Essential Medicines List, if approved, would make it the first weight-loss medication to be included in the list. This could potentially pave the way for other weight-loss drugs, including newer and more potent medications like Wegovy, to also be considered for inclusion in the list in the future.

Novo Nordisk, the same pharmaceutical company that produces Wegovy and Ozempic, manufactures liraglutide. Ozempic (semaglutide) is also an FDA-approved drug for weight management and type 2 diabetes, while it is used off-label for weight loss.

The proposal to include GLP-1 receptor agonists such as liraglutide in the Essential Medicines List was put forth by a group of four researchers from American institutions, namely Yale University, Brigham and Women’s Hospital, and the University of California at San Francisco.

The patent for liraglutide in the United States is due to expire later this year after a settlement was reached between Novo Nordisk and another manufacturer. This will allow for generic versions of the drug to become available from June 2024 onwards.

Novo Nordisk has not been directly involved in the process and has issued a statement to Reuters expressing their support for the WHO review, stating that they “welcome the WHO review and look forward to the readout and decision.”

CRUCIAL QUOTE

The researchers who submitted the request to the WHO emphasized the urgent need for weight-loss medications to be included in the Essential Medicines List, stating that “At present, there are no medications included in the (Essential Medicines List) that specifically target weight loss for the global burden of obesity.” They further highlighted that despite mineral supplements for nutritional deficiencies being listed, “most of the population live in ‘countries where overweight and obesity kills more people than underweight.’”

CHIEF CRITIC

Francesco Branca, the WHO director for nutrition and food safety, expressed some reservations about the potential inclusion of liraglutide in the Essential Medicines List. At a briefing on Wednesday, he stated that while the drug has been around for a while, its use for weight loss may not have been long enough to warrant inclusion in the list. He also pointed out concerns related to the cost of treatment. However, he did acknowledge that WHO is actively reviewing guidelines for the use of weight-loss drugs in children and adolescents, suggesting that the issue is still under consideration.

BIG NUMBER

The number of adults worldwide who are obese is estimated to be around 650 million, which is more than triple the number reported in 1975. Additionally, WHO estimates that there are around 1.3 billion overweight adults globally. In 2016, over 340 million children aged between five and 19 were classified as overweight or obese, while in 2020, 39 million children under the age of five were also considered either overweight or obese. Alarmingly, 70% of overweight or obese individuals live in low- or middle-income countries.

KEY BACKGROUND

The WHO Expert Committee on the Selection and Use of Essential Medicines is set to meet in late April to discuss updates and revisions involving several drugs, including liraglutide. The Essential Medicines List is a biennial registry of over 1,300 minimum essential medications required by every healthcare system across the globe. The list aims to provide low-cost, effective drugs for better healthcare, lower costs, and improved long-term medicine supply. The addition of liraglutide to the list could make the drug available globally at an affordable cost, as it would pave the way for other weight-loss medications. According to a study, the average cost of liraglutide for a 30-day dose is $1,418 in the US, which is higher than other weight-loss drugs. Around 650 million adults worldwide are obese, and 1.3 billion are overweight, with over 70% of overweight or obese people living in low- or middle-income countries. The WHO has been criticized for labeling obesity as preventable while not including any medications to treat this chronic condition on its list.

SURPRISING FACT

The addition of antiretroviral drugs to the 2002 list is believed to have played a significant role in increasing access to HIV medication for patients in impoverished nations.

EFFECTIVENESS COMPARE TO SEMAGLUTIDE

Saxenda, a weight loss medication, was approved by the FDA based on data from three phases III trials known as Satiety and Clinical Adiposity—Liraglutide Evidence in Nondiabetic and Diabetic People (SCALE). These trials involved over 5,000 participants who were overweight or obese with or without other weight-related conditions. Results showed that patients who took Saxenda achieved a weight loss of 5% to 10% over 56 weeks compared to those in the placebo group. Similarly, a study published in the New England Journal of Medicine found that semaglutide, another GLP-1 agonist, led to an average weight change of 14.9% compared to 2.4% in the placebo group over a 68-week period. Another study focused on liraglutide use in children and adolescents with type 2 diabetes and showed significant reductions in BMI and weight by week 52. While the long-term effects of liraglutide use are not well-known, studies on other GLP-1 agonists have indicated that patients regained weight after stopping the medication. In fact, a study revealed that patients who stopped taking semaglutide regained 11.6% of their lost weight by week 120, while another study showed that patients gained two-thirds of their body weight back a year after stopping the medication.

SIDE EFFECTS

Liraglutide, a medication used for weight loss, can cause mild side effects such as constipation, heartburn, headache, and a rash at the injection site, as reported by MedlinePlus. However, more serious complications may also occur, including nausea, diarrhea, suicidal thoughts, depression, yellowing of the skin or eyes, and swelling of the mouth, eyes, tongue, or throat. The drug may also increase the risk of thyroid cancer. If a patient experiences difficulty breathing or swallowing, a lump or swelling in the neck, hoarseness, or shortness of breath, they should consult their primary care physician immediately.

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