A government-backed expert panel in India has recommended the approval of Eli Lilly's weight loss medication, Mounjaro (tirzepatide), Reuters reports.
This decision paves the way for the import and sale of the drug in India, offering a new treatment option for millions struggling with obesity (classified by experts as a chronic complex disease) and type 2 diabetes.
This photograph taken on February 23, 2023, in Paris, shows the anti-diabetic medication "Ozempic" (semaglutide) made by Danish pharmaceutical company "Novo Nordisk".Photo by JOEL SAGET/AFP via Getty Images
Obesity Drug Regulatory Approval Pending Phase 4 Trial and Manufacturing Data
Mounjaro, chemically known as tirzepatide, is part of a class of therapies known as GLP-1 receptor agonists. These drugs, including Novo Nordisk's Wegovy and Ozempic, were initially developed to control blood sugar levels in patients with type 2 diabetes.
However, they have gained immense popularity as weight loss treatments due to their ability to slow digestion, helping patients feel full longer and reduce their overall calorie intake.
The approval is contingent upon Eli Lilly conducting a Phase 4 clinical trial to monitor the drug's safety and effectiveness in real-world settings. Additionally, the company must submit manufacturing and control data to meet India's regulatory standards.
According to a notification dated June 19, the committee stated, "After detailed deliberation, the committee recommended for grant of permission for import and marketing" of tirzepatide for chronic weight management, with the condition of conducting Phase 4 clinical trials.
Sheetal Sapale, vice president of the research firm Pharmarack noted, "A recommendation from the subject expert committee is like the penultimate step of the approval."
The Indian Practitioner reports that Eli Lilly has proposed importing and marketing six dosages of tirzepatide in both single-dose prefilled pens and single-dose vials. The company's proposal was supported by India-specific clinical study reports derived from two global studies that included Indian participants.
Notably, the prefilled pen formulation has already been approved in several regions, including the United States, European Union, United Kingdom, United Arab Emirates, Hong Kong, Kuwait, and Qatar. Additionally, the single-dose vials are approved in the US, EU, and Egypt for chronic weight management.
Eli Lilly's CEO, David Ricks, indicated that the company expects to launch Mounjaro in India as early as next year. Reuters tells us that the global weight-loss drugs market is projected to reach at least $100 billion by the end of the decade, mirroring the growing demand for effective obesity treatments.
Meanwhile, Nature reported in June that Chinese and Indian pharmaceutical companies are developing biosimilars-cheaper versions of existing drugs, such as GLP-1 mimics-that help with weight loss and diabetes management.
This shift could significantly lower costs, potentially expanding the market and increasing access to these treatments. Some companies are innovating beyond biosimilars, developing improved versions of these drugs, which may offer enhanced effectiveness and affordability.
