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Eli Lilly took one step closer to approval for the marketing of tirzepetide for its obesity treatment in the US. made to do.
company said on thursday That the Food and Drug Administration gave tirzepatide in the indication of obesity in the so-called fast track designation, which speeds up the review of drugs that address serious conditions without medical need.
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The company said this designation would allow Lilly (ticker: LLY) to submit its application for the approval of tyrazepatide in obesity this year. Lilly will finalize its application once the results of the second Phase 3 trial of the drug are out, which is expected to be available by the end of next April.
The FDA approved tirazeptide in May for the treatment of type 2 diabetes. It is sold in America under the name Monjaro. It is not yet approved for the treatment of obesity.
Lilly was widely expected to receive a fast track designation for tirzepetide, and shares are up 0.8% in Thursday morning trading, while the S&P 500 is nearly flat. According to FactSet, Lilly stock is up 21% so far this year, and the stock trades at 37 times earnings over the next 12 months, the highest ever for its large pharma peer group.
“This is something the Street was anticipating, given the strong results of LLY’s obesity study,” Cantor Fitzgerald analyst Lewis Chen wrote in a note early Thursday. “But to be confirmed is obviously good news.” Chen rates Lilly stock overweight with a $360 price target.
Lilly’s Phase 3 Trial of Tirazeptide in Obesity has shown that participants on the moderate dose lost an average of 21.4% of their weight, compared to 2.4% in those receiving the placebo. In the medium-sized dosage group, 55% of participants lost at least 20% of their body weight.
At the highest dose level, 63% of participants lost at least 20% of their body weight, and an average of 22.5% of their body weight.
as baron’s Reported in August, Lilly is competing with Novo Nordisk (NVO), which received FDA approval for a similar drug last year.
“We are pleased with the FDA’s decision to grant a fast track designation for terzepetide, and we look forward to completing our rolling submission next year,” Mike Mason, president of Lilly Diabetes, said in a statement.
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