Eli Lilly Beats Ozempic-Maker In Approval For India's First Weight Loss Drug
Once approved by the Indian drug regulator, Eli Lilly will sell it under two brand names—Mounjaro and Zepbound.
Pharmaceutical company Eli Lilly and Co. has beaten Ozempic manufacturer Novo Nordisk AS in acquiring initial approvals for import to and marketing of a weight-loss drug in India. Once approved by the Indian drug regulator, Eli Lilly will sell it under two brand names—Mounjaro, which is chemically known as tirzepatide, and Zepbound.
The Eli Lilly drugs were primarily meant for treatment of people with type 2 diabetes, and can be prescribed for weight management. Competitor Novo Nordisk markets Ozempic and Wegovy for similar purposes.
Eli Lilly presented its proposal to the Subject Expert Committee under the Central Drugs Standard Control Organisation for the grant of permission to import and market Tirzepatide 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml and 15mg/0.5ml solutions in India, according to a recent statement by the Indian drug regulator.
Tirzepatide is a combination of the glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors. The medicine significantly enhances glycemic control and weight loss in type 2 diabetes patients, with benefits comparable to GLP-1 drugs, such as semaglutide.
Notably, Eli Lilly has gotten the approval from the subject expert committee as of now. It has not received approval from the Indian drug regulator yet.
The pharma company plans to market the drug as both an injection in a single dose pre-filled pen and in a single-dose vial. It also presented India-specific reports from two global clinical studies, in which India is also one of the participating country before the committee.
Tirzepatide single dose vials are approved in the United states, the European Union and Egypt for chronic weight management.
The SEC approved the move on the condition that the firm should conduct Phase-4 clinical trial and fulfill the requirement of Chemistry Manufacturing and Controls data.
Ozempic, Wegovy, Mounjaro and the entire line of such medication can reduce hunger and blood-sugar. Although not marketed as weight-loss drugs, people continue to use it, ignoring doctors' warnings.
Several Indians have been stashing boxes of Ozempic injectables in their carry-on luggage, buying counterfeit formulas online and importing boxes from Europe, according to a Bloomberg report.
The race to score the 'miracle' drug that has become popular among celebrities and the wealthy has created a global shortage.
