New Delhi: US pharma giant Eli Lilly and Company launched its fat-busting injection Mounjaro for the treatment of obesity and type 2 diabetes in India Thursday, paving way for wider and easier access to the drug that could, thus far, only be accessed in the country by a handful of patients able to get the imported versions.
Mounjaro’s active pharmaceutical ingredient (API) is tirzepatide, which works by binding to the receptors of various gut hormones that regulate the secretion of pancreatic hormones as well as gut function.
The drug, which has been a global blockbuster drug since its launch in the US in 2022, is a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist that improves insulin secretion and sensitivity, and delays gastric emptying, which leads to a feeling of stomach fullness for a longer duration, lowering appetite.
In the US, the drug is available under two brand names—Mounjaro for diabetes and Zepbound for managing obesity.
Adults taking Mounjaro with diet and exercise in controlled clinical trials lost, on an average, 21.8 kg at the highest dose (15mg) and 15.4 kg at the lowest dose (5mg) over a period of 72 weeks.
“The launch of Mounjaro (tirzepatide) marks a significant milestone as a first-in-class GIP and GLP-1 agonist, approved for both type 2 diabetes and obesity in India,” Lilly India said in a statement.
The company, which had received the regulatory approval for the drug by the Central Drugs Standard Control Organisation (CDSCO) last year, is launching it in two strengths—2.5 mg vial priced at Rs 3,500 and 5 mg vial at Rs 4,375. The starting dose of 2.5 mg of the weekly injectable medicine will, therefore, be available for Rs 14,000 per month.
A 5 mg vial of the drug was available for Rs 10,000-15,000 in the country so far.
“This India-specific pricing reflects Lilly’s commitment to expanding access to innovative treatments in the country,” the company said in response to a query by ThePrint.
Endocrinologists that ThePrint spoke to called the new launch a game-changer for India’s healthcare landscape, which is riddled by the acute dual burden of diabetes and obesity.
“There has been a lot of interest among patients for the drug’s effect on diabetes and weight management, but very few could get it. Also, reliability of the drug was always under question because one could not be sure whether the drug was genuine. Standard pharmacists now keeping the drug will make it accessible to millions who could benefit from it,” said Dr Ambrish Mithal, chairman and head of endocrinology and diabetes at Max Healthcare in Delhi.
He, however, added that there could also be a risk of misuse of the drug in the country, if patients start taking it without the supervision of the doctors. “That’s a possible concern and I think there should be strict monitoring to ensure that the medicine is not sold over the counter without a doctor’s prescription. It remains to be seen how that unfolds.”
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‘Better efficacy than currently used drugs’
About 101 million people in India are affected by diabetes, and nearly half of these in the adult patients category are being inadequately treated with suboptimal glycemic control.
On the other hand, obesity, a chronic relapsing disease, is a major risk factor for diabetes, and 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 percent, affecting nearly 100 million people.
The growing obesity crisis in the country has also been highlighted by Prime Minister Narendra Modi on several occasions this year, who made a strong pitch to curb the menace. In his monthly radio broadcast Mann Ki Baat in February, he called on people to reduce the use of cooking oils commonly found in unhealthy food. Before this, he had also urged people to adopt an active and healthy lifestyle in order to prevent obesity.
The new drug launched by Eli Lilly, meanwhile, 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 also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Tirzepatide was evaluated in two robust global clinical development programmes—SURMOUNT-1 trials for chronic weight management and SURPASS trials for type 2 diabetes.
In SURMOUNT-1, a study involving 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 to placebo at 72 weeks, according to details shared by the drugmaker.
At the highest dose (15 mg), people taking Mounjaro lost 21.8 kg on average, while those taking the lowest dose (5 mg) lost 15.4 kg on average (compared to 3.2 kg on placebo).
Additionally, one in three patients taking Mounjaro at the highest dose lost over 26.3 kg (25 percent of body weight), compared to 1.5 percent on placebo. On average, the medicine reduced weight by up to 21.8 kg in the SURMOUNT-1 study.
In Phase 3 of SURPASS programme, 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 this programme achieved average A1C reductions—glycated hemoglobin test for patients with diabetes over 2-3 months—between 1.8 and 2.1 percent for Mounjaro 5 mg, between 1.7 and 2.4 percent or both for Mounjaro 10 mg and 15 mg over the period of 40 weeks.
Overall, the programme demonstrated that the drug, whether used alone or with other diabetes medications, reduced A1C by up to 2.4 percent.
“Obesity and diabetes are recognised as serious conditions linked to various life-limiting health complications, making effective and sustained treatment critical. The drug 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.
Dr Mithal pointed out that the drug may offer hope for patients who, in the absence of tirzepatide and its close competitor semaglutide (in high strengths), had to rely on their predecessors, such as dulaglutide and liraglutide.
Semaglutide, under the brand names Ozempic and Wegovy, has been a global hit, but only in the oral version under the brand name Rybelsus. It has been available in the country in 3 mg, 7 mg and 14 mg formulations, and is indicated for type 2 diabetes.
India’s CDSCO has approved Ozempic and Wegovy, too, but the drugs are yet to be launched locally mainly due to supply constraints and high demand in developed countries. “These drugs have shown to be far more efficacious in managing diabetes and obesity, and now there is also long-term data available to boost the confidence of clinicians and patients,” Dr Mithal said.
These drugs, however, come with side-effects, which mostly include gastrointestinal reactions, which can be severe in rare cases.
Another caveat with this class of medicine is the return of body fat once a patient goes off the drug.
(Edited by Mannat Chugh)
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