India approves 2 weight loss drugs — Mounjaro and Zepbound: Here’s all you need to know

Mounjaro addresses diabetes more while Zepbound targets weight loss. Both will be available in a pre-filled pen and have to be injected subcutaneously (under the skin). In a statement to The Indian Express, the makers said, “Eli Lilly has received marketing authorisation for Type 2 diabetes indication for Tirzepatide in India. Application for obesity indication is undergoing review by CDSCO. Launch timelines for India have not been confirmed yet.”

WHY THE EXPERTS CLEARED THE DRUG

The committee has approved the import of single dose vials and pre-filled pens of the injectable drug in six different doses, ranging from 2.5 mg to 12.5 mg. This nod is based on two global clinical trials, which also included a significant number of Indians. In a trial of adults without type 2 diabetes, those on the highest dose of Tirzepatide lost an average of 18 per cent of their body weight in 72 weeks. And, in a trial among those with diabetes, participants lost an average of 12 per cent of their body weight.

WHY TIRZEPATIDE HAS AN EDGE OVER SEMAGLUTIDE

Semaglutide belongs to a class of drugs called GLP-1 receptor agonists, which lower serum glucose levels. Tirzepatide mimics both the GLP-1 hormone and the GIP hormone. The latter can trigger insulin creation and sensations of fullness, thereby increasing the chances of weight loss.

WILL THERE BE CHECKS AND BALANCES?

Eli Lilly has been asked to submit a protocol for a phase IV trial within three months.  “The committee recommended grant of permission for import and marketing of Tirzepatide for chronic weight management … subject to the condition that the firm should conduct Phase-IV clinical trial,” according to the minutes of the meeting of the subject expert committee on endocrinology and metabolism held last month. A phase IV trial is important as it tracks people who have taken a new drug to study the side effects over time.

WHO CAN USE THE DRUGS?

The panel advised doctors to select the patients very carefully. “It should not be given to people with a history of pancreatic diseases, disorders of the endocrine systems, nausea and vomiting. The patients should also be asked to follow a diet and exercise first. The drug should be prescribed only when they are able to maintain the same weight level or bring it down by adhering to it,” the expert said.

ARE THE DRUGS EFFECTIVE?

Dr V Mohan, chairman, Dr V Mohan’s Diabetes Specialities Centre, Chennai, says the dosage should follow only after the patient has done lifestyle modifications and is still hovering around the body mass index (BMI) of 30. “These drugs may help knock off the weight initially but to sustain the weight loss, you will still need a diet, exercise and sleep discipline. Also the drugs need to be graded according to individual response as they do not work the same way for all,” says he, adding fats have a tendency to come back one you discontinue drug use.

CAN EVERYBODY AFFORD THESE DRUGS?

Although the committee’s brief is not to discuss pricing, these are expected to cost around Rs 15,000 a month. Long-term use would be a drain on the resources.