Post CDSCO approval, Lilly launches Mounjaro, a first of its kind treatment for obesity & type 2 diabetes

New Delhi: Eli Lilly and Company (India) has announced the launch of Mounjaro^® in single-dose vial presentation following the marketing authorization from the Central Drugs Standard Control Organization (CDSCO).

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.

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. Mounjaro^® is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

“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,” said Winselow Tucker, President and General Manager, Lilly India. “Our mission to making life better for people living with obesity and diabetes in India is reflected in our efforts to accelerate the introduction of innovative medicines. The launch of Mounjaro^® demonstrates our ongoing support to this mission and our shared vision of a healthier nation.”

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). 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. 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. Overall, the program demonstrated that Mounjaro^®, whether used alone or with other diabetes medications, reduced A1C by up to 2.4%.

India has about 101 million people living with diabetes and nearly half of these in the adult patients category are being inadequately treated with suboptimal glycemic control. Obesity, a chronic relapsing disease, is a major risk factor for diabetes, is linked to over 200 health complications, including hypertension, dyslipidemia, coronary heart disease, and obstructive sleep apnea. As of 2023, adult obesity prevalence in India stood at around 6.5%, affecting nearly 100 million people.

“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.

Once-a-weekly, prescription-based medicine, Mounjaro^® is a single molecule that selectively binds to and activates both GIP and GLP-1 receptors, which are natural incretin hormones.

In a glucose-dependent manner, Mounjaro^® improves first phase and second phase insulin secretion, and reduces glucagon levels; it also improves insulin sensitivity and delays gastric emptying. GIP receptors and GLP-1 receptors are both expressed in important areas of the brain that regulate appetite. Mounjaro^® reduces food intake, body weight, and decreases fat mass by regulating appetite; moreover, Mounjaro^® has been demonstrated to regulate lipid utilization. Mounjaro^® (tirzepatide) has already had a tremendous impact on millions of people living with type 2 diabetes and obesity, respectively.