Eli Lilly‘s blockbuster drug ‘Mounjaro’ was launched in India on Thursday. The pharma manufacturer said it has launched a first-of-its-kind medication for obesity and type 2 diabetes in the country after obtaining approval from the Central Drugs Standard Control Organisation (CDSCO). The company said it has introduced Mounjaro in a single-dose vial presentation following the marketing authorisation from the CDSCO.
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. It is a first-of-its-kind treatment for obesity, overweight, and type 2 diabetes that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.”The dual burden of obesity and type 2 diabetes is rapidly emerging as a major public health challenge in India. Lilly is committed to collaborating with the government and industry to promote awareness and improve the prevention and management of these diseases,” Eli Lilly India President and General Manager Winselow Tucker said.
The introduction of Mounjaro is a ray of hope for India, as over 100 million people are already affected with diabetes and a major part of the population is obese. Obesity, a chronic relapsing disease, is a major risk factor for diabetes and is linked to over 200 health complications, including hypertension, dyslipidemia, coronary heart disease, and obstructive sleep apnea.
While Mounjaro’s introduction to the Indian market seems to have a positive impact in the fight against obesity, one should also be careful about the side effects.
Several experts have welcomed the drug and have also spoken about its side effects. For example, Dr Keith Siau took to X to share the side effects of Mounjaro. “GLP1 receptor agonists such as Mounjaro / Ozempic are now easily purchasable without a prescription, but watch out for side effects,” he has posted on X.
Many users experience gastrointestinal discomfort, including nausea, vomiting, diarrhea, and constipation. These side effects are usually mild and improve over time as the body adjusts. Loss of appetite is another common effect, which contributes to weight loss but may lead to nutritional deficiencies if not managed properly.
Some individuals may develop pancreatitis, a serious condition marked by severe abdominal pain, nausea, and vomiting. There is also a risk of hypoglycemia (low blood sugar), especially if Mounjaro is taken alongside insulin or other diabetes medications. Symptoms of hypoglycemia include dizziness, sweating, shakiness, and confusion.
Gallbladder issues, such as gallstones or gallbladder inflammation, have been reported in some users. Additionally, there is a potential but rare risk of thyroid tumors, as observed in animal studies. While human studies have not confirmed this risk, those with a history of thyroid cancer should exercise caution.
Individuals with pancreatitis, thyroid disorders, severe gastrointestinal conditions, or gallbladder disease should consult a doctor before taking Mounjaro. Regular monitoring and lifestyle adjustments can help minimize risks.
Tirzepatide was evaluated in two robust global clinical development programs: the SURMOUNT – 1 trials for chronic weight management and the SURPASS trials for type 2 diabetes.
In SURMOUNT-1, a study in 2,539 adults with obesity, or excess weight and weight-related medical problems not including diabetes, people taking Mounjaro as an adjunct to diet and exercise experienced substantial weight loss compared with placebo at 72 weeks. At the highest dose (15 mg), people taking Mounjaro lost on average 21.8 kg, while at the lowest dose (5 mg), people lost on average 15.4 kg (compared to 3.2 kg on placebo).1,2 Additionally, 1 in 3 patients taking Mounjaro at the highest dose lost over 26.3 kg (25% of body weight), compared to 1.5% on placebo, according to data not controlled for type 1 error.1,2 In summary, Mounjaro significantly reduced weight by up to 21.8 kg in the SURMOUNT-1 study.
In phase 3 SURPASS program, efficacy was evaluated for Mounjaro 5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro® 5 mg and between 1.7% and 2.4% for both Mounjaro 10 mg and Mounjaro 15 mg over the period of 40 weeks.3-6 Overall, the program demonstrated that Mounjaro, whether used alone or with other diabetes medications, reduced A1C by up to 2.4%.
“Obesity and diabetes are recognized as serious conditions linked to various life-limiting health complications, making effective and sustained treatment critical. We are thrilled to introduce Mounjaro in India to address these unmet medical needs. Mounjaro may offer a new approach to metabolic health management, providing healthcare providers with an innovative option to treat these diseases.” said Dr. Manish Mistry, Senior Medical Director, Lilly India.