Lilly's Mounjaro is on the Fast Track Toward Potential Obesity Approval

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Courtesy of Cristina Arias/Getty Images

Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity. 

Mounjaro was previously approved by the FDA in May to treat Type 2 Diabetes. After discussions with the regulator, Lilly expects to initiate a rolling submission later this year for a New Drug Application in adults with obesity. 

The submission will be built on data from the completed Phase III SURMOUNT-1 trial and the SURMOUNT-2 trial which is scheduled to wrap by the end of April 2023. With the rolling submission, the Fast Track designation will give Lilly a shorter timeline for approval.

“SURMOUNT-1 showed promising results for [the] obesity indication, delivering up to 22.5% weight loss in adults with obesity or overweight,” said Jessica Thompson, an Eli Lilly spokesperson in a statement to BioSpace.

Tirzepatide is a once-weekly glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist.

A Highly Competitive Market

Weight loss to treat obesity and overweight has become a new battleground for diabetes drugs. Many, including glucagon-like peptide-1 (GLP-1) receptor agonists, are very effective in treating T2D 

These drugs include Lilly’s Trulicity, AstraZeneca’s Bydureon and Byetta, Novo Nordisk’s Ozempic, Rybelsus, Victoza and Saxenda and Sanofi’s Adlyxin.

While the T2D market has been competitive, many are now using the same drugs to treat obesity. Morgan Stanley Research reports the obesity treatment market was about $2.4 billion in 2022 but is expected to grow to $54 billion by 2030. 

Lilly and others in the space are testing their diabetes drugs for obesity and against each other.

For example, Lilly announced additional data in June from a Phase I mechanism of action study of its injectable tirzepatide versus Novo Nordisk’s semaglutide (Ozempic) in adults with T2D, with a focus on weight loss.

The study found patients receiving the 15mg Mounjaro regimen lost 24.7 pounds of body weight after 28 weeks compared to 15.2 pounds in the 1mg semaglutide cohort. Patients receiving a placebo did not lose weight.

In June 2021, Novo Nordisk’s Wegovy (once-weekly semaglutide 2.4mg self-injection) became the first and only once-weekly GLP-1 agonist approved by the FDA for chronic weight management. When used to treat T2D, it uses the brand name Ozempic at a higher dose.

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