Global pharmaceutical company Eli Lilly is targeting a 2025 launch for its tirzepatide-based drugs, Mounjaro and Zepbound, in India, designed to treat both diabetes and obesity. The launch is contingent upon securing necessary regulatory approvals, which are currently under review by Indian authorities.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) assessed Eli Lilly’s proposal in August 2024 to import and market a multi-dose prefilled pen version of tirzepatide, offered in dosages ranging from 2.5 mg to 15 mg. While a single-dose prefilled pen format of tirzepatide was approved in January 2024 as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes, this approval was conditional, requiring Eli Lilly to conduct a Phase IV clinical trial within India.
Regulatory Hurdles for Multi-Dose Pen
Eli Lilly's submission for the multi-dose pen included a bioequivalence (BE) study conducted in the United States. However, the SEC identified that the study, which compared a multi-dose pen with a preservative to the single-dose pen without a preservative, did not meet the predefined criteria for maximum drug concentration (Cmax) in the bloodstream. The committee also emphasized the need for data specific to the Indian population. Consequently, the SEC has requested interim efficacy data from the ongoing Phase IV trial in India, along with global safety and efficacy data on the multi-dose pen, before further evaluation. According to government sources, Eli Lilly has yet to present the requested data.
Company's Commitment to Launch
Despite the regulatory challenges, Eli Lilly remains committed to its projected launch timeline. Vineet Gupta, Associate Vice President and Managing Director of Eli Lilly (India), stated, "India continues to be an important market for Lilly, and we are committed to accelerating the process of bringing our innovative products to the country. We aim to launch tirzepatide in India by 2025, after obtaining all necessary regulatory approvals. The burden of diabetes and obesity is rising in India, and we believe there is a great opportunity to serve the needs of Indian patients."
Gupta also highlighted the importance of treating obesity as a chronic disease, advocating for comprehensive care that includes lifestyle modifications, medication, and bariatric surgery when necessary.
Mounjaro's Approval and Phase IV Trial Requirements
In a related development, the SEC recently recommended granting permission for the import and marketing of Eli Lilly’s weight loss drug, Mounjaro (tirzepatide), in India. This approval, granted in June 2023, covers six doses of the drug in single-dose prefilled pens and vials, subject to Eli Lilly conducting Phase IV clinical trials and meeting all quality and manufacturing data requirements. Mounjaro is already approved in the United States, the European Union, and other countries for chronic weight management and as an adjunct to diet and exercise for type 2 diabetes. Eli Lilly is required to submit its Phase IV trial protocol to CDSCO within three months of the drug’s approval for further review.
Tirzepatide's Mechanism of Action
Mounjaro is recognized as a significant advancement in the treatment of both diabetes and obesity. Eli Lilly has reported that the drug activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) pathways to help regulate blood sugar. These hormones signal the pancreas to release insulin after eating, which lowers blood sugar. GIP stimulates insulin production, while GLP-1 also reduces sugar production in the liver and helps control hunger, thereby managing blood sugar levels, particularly in individuals with diabetes.
Following its FDA approval for Mounjaro in May 2022, the company has announced plans to expand manufacturing capacity to meet global demand. In the competitive weight loss drug market, Eli Lilly recently announced that Zepbound outperformed Novo Nordisk’s Wegovy (semaglutide) in a recent clinical trial.
