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Expert panel urges drug regulator to approve Lilly’s obesity drug Mounjaro

July 01,2024

Hyderabad: An Indian government-approved expert panel has advised the country’s drug regulator to approve the import and sale of U.S. drugmaker Eli Lilly’s Mounjaro, a blockbuster diabetes drug and a wildly popular obesity treatment, a document on a government website showed on Monday.

Lilly’s Mounjaro, chemically known as tirzepatide, and Zepbound and Danish rival Novo Nordisk’s Wegovy and Ozempic belong to a class of therapies known as GLP-1 receptor agonists, developed to control blood sugar in patients with type 2 diabetes.

They also slow digestion, helping patients feel full longer, making them a wildly popular choice for weight loss.

“After detailed deliberation, the committee recommended for grant of permission for import and marketing” of certain doses of tirzepatide “for chronic weight management subject to the condition that firm should conduct Phase 4 clinical trial (post-marketing surveillance),” the Subject Expert Committee said in a notification dated June 19.

The committee advises India’s drug regulator on approvals of drugs and trials.

“A recommendation from the subject expert committee is like the penultimate step of the approval,” said Sheetal Sapale, vice president of research firm Pharmarack.

Lilly did not immediately respond to a Reuters request for comment. CEO David Ricks had told Reuters a few months back that the company expected to launch Mounjaro in India as early as next year.

India has the world’s second-highest number of people with type 2 diabetes and high obesity rates. Around 11% of Indian adults will be obese by 2035, per the World Obesity Federation Atlas. The global weight-loss drugs market is estimated to reach at least $100 billion by the decade’s end.

Lilly should also submit the required manufacturing and controls data, the expert panel added.

The notification was first reported by a local medical journal, The Indian Practitioner. (Reporting by Rishika Sadam; Editing by Dhanya Skariachan and Savio D’Souza)

Source: Pharma

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