Eli Lilly and Co LLY-N said on Thursday the U.S. Food and Drug Administration (FDA) had agreed to a quick review of its diabetes drug Mounjaro to treat obesity, months after a study showed it helped people lose more than 20 per cent of their weight.
The FDA granted the “fast track” status to the drug, which makes it eligible for an expedited review. The company now plans to submit data on a rolling basis this year and expects more data early next year.
The developments come as obesity continues to be a major health concern in the United States, with the disease estimated to have affected more than 40 per cent of the population and cost nearly $173-billion annually, according to federal data.
The FDA had approved Mounjaro for the treatment of Type 2 diabetes in May. The drug – also known as tirzepatide – is expected to become a blockbuster treatment if approved for obesity, and compete with Novo Nordisk’s Wegovy.
Newer obesity drugs such as Wegovy and Mounjaro as well as diabetes drugs are also expected to dramatically improve conditions that lead to kindey failure.
Eli Lilly in April had reported that the drug had achieved a goal of helping patients lose more than 20 per cent of their weight in a late-stage clinical trial, prompting analysts to increase their peak sales estimate for the drug.
Wells Fargo analyst Mohit Bansal said the fast-tracked review could be six months or shorter after the company completes its submission of data, making an approval likely by the end of next year and setting Lilly up for potential boost to earnings from 2024.
Bansal had in April estimated for tirzepatide’s sales as an obesity drug to be $7.5-billion while expecting total sales of the drug’s franchise to hit $18-billion at peak.