Home Investing FDA fast tracks Eli Lilly’s obesity drug: ‘this is the Holy Grail’

FDA fast tracks Eli Lilly’s obesity drug: ‘this is the Holy Grail’

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Eli Lilly & Co (NYSE: LLY) is in focus on Thursday after the pharmaceutical giant said the U.S. FDA agreed to a speedy review of Tirzepatide for the treatment of obesity and weight-related comorbidities.

Why does that matter?

A late-stage clinical trial has already shown “Mounjaro” to be effective for weight-loss, which enables Lilly to report data on a rolling basis. The press release reads:

Lilly plans to initiate a rolling submission of a new drug application (NDA) for Tirzepatide in adults with obesity this year, which when complete, will be based on results from two Phase 3 clinical trials.

The second study is currently ongoing and is slated to complete in April 2023.

Over 40% of the U.S. population is estimated to struggle with obesity. The “fast track” designation from the Food & Drug Administration means Lilly’s treatment will be available to these patients sooner.

Jim Cramer reacts to the news

Shares of Eli Lilly are already up more than 20% for the year. Thanks to its obesity drug, though, UBS says another 10% is yet to unlock. It forecasts Mounjaro to eventually bring in north of $25 billion annually for the healthcare company.

Among other notable names that are positive on Eli Lilly for Tirzepatide is Jim Cramer. This morning on CNBC’s “Squawk on the Street”, he said:

It’s interesting how much people want this. All the stars that’re worried about their weight are getting this. There are no side effects, this is kind of the Holy Grail. It’s a revolutionary drug. You take one and you lose weight. There’s never been a drug on the market that does this.

Obesity in the U.S. is estimated to cost $173 billion annually.

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