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India panel urges drug regulator to approve Lilly's obesity drug Mounjaro
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India panel urges drug regulator to approve Lilly's obesity drug Mounjaro
Jul 1, 2024 5:51 AM

By Rishika Sadam

HYDERABAD, July 1 (Reuters) - 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 ( LLY ) 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.

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