Context: In a significant move, scientists from the World Health Organization
(WHO) have endorsed a new class of medicines known as GLP-1 receptor agonists
(GLP-1 RAs), which mimic a hormone that regulates appetite and blood sugar
levels, to manage obesity. Globally, one in eight people were obese in 2022,
according to WHO. The WHO is currently in the process of drafting guidelines
for the use of GLP-Ras in adults with obesity to provide clarity on ‘clinical
indications and programmatic considerations globally’. The guidelines are
likely to be published in July 2025. There has also been a significant increase
in childhood obesity over the last three decades in India resulting from 2 lakh
boys and girls each in 1990 to 73 lakh boys and girls in 2022.
Key points
· Overview: Recently, in a
first, an expert committee of India’s drug regulator gave the green light to
the drug tirzepatide and India could soon allow ‘game-changing’ weight-loss
drug tirzepatide.
· Diabetes
Drug for Weight Loss: In 2017, the US Food and Drug Administration (FDA)
approved a drug called Ozempic for managing type 2 diabetes. The active
ingredient, semaglutide, was later noted for causing weight loss, which led to
its off-label use for treating obesity.
· Tirzepatide
and Semaglutide: These two weight loss drugs have been approved by
the FDA for chronic weight management in adults. Semaglutide and tirzepatide
are polypeptides, small proteins that boost the levels of naturally occurring
hormones in the body, including that of glucagon-like-peptide 1 (GLP-1), which
control weight through the brain and digestive tract.
Functioning - Higher GLP-1
levels, released in the gut, spark a reaction by stimulating neurons that alter
gut function, leading to a sense of fullness. They also help manage glucose
levels, making them an effective treatment for diabetes.
Side effects - Nausea,
diarrhoea, vomiting, constipation, abdominal pain, indigestion, injection-site
reactions, fatigue, allergic reactions, belching, hair loss, and heartburn.
· Significance
of the drugs: These drugs can be prescribed to those who are
obese (with a body mass index of over 30), or overweight (with a BMI between 27
and 30), and have at least one other health condition related to their weight
(such as high blood pressure, high cholesterol, or type 2 diabetes).
· Promising
Global Trials: Global clinical trials for tirzepatide (Zepbound)
have shown significant results, with the highest dosage leading to an average
weight loss of 20.9% over 72 weeks. The approval in India is due on further
post-marketing surveillance (Phase IV trials) to monitor the drug’s side
effects and its effectiveness across India’s diverse population.
· Central
Drugs Standard Control Organisation (CDSCO): CDSCO is India’s national
regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a
similar function to the Food and Drug Administration (FDA) of the US or the
European Medicines Agency of the European Union.