Benzinga - by Vandana Singh, Benzinga Editor.
The FDA has approved Eli Lilly And Co's (NYSE: LLY) Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
The active ingredient in the drug, tirzepatide, has already been approved for Type 2 diabetes under the name Mounjaro since May 2022.
Mounjaro (Type 2 diabetes injection) Q3 sales reached $1.41 billion compared to $187.3 million a year ago.
The approval was based on results from the phase 3 SURMOUNT-1 and SURMOUNT-2 trials. At the highest dose (15 mg), people taking Zepbound lost on average 48 lb., while at the lowest dose (5 mg), people lost on average 34 lb. (compared to 7 lb. on placebo).
Additionally, 1 in 3 patients taking Zepbound at the highest dose lost over 58 lb. (25% of body weight), compared to 1.5% on placebo.
Zepbound is expected to be available in the U.S. by the end of the year in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) at a list price of $1,059.87, which is approximately 20% lower than Nova Nordisk A/S's (NYSE: NVO) semaglutide 2.4 mg injection for weight loss (Wegovy and Ozempic).
People who are commercially insured with coverage for Zepbound may be eligible to pay as low as $25 for a 1-month or 3-month prescription.
People who are commercially insured without coverage for Zepbound may be eligible to pay as low as $550 for a 1-month prescription of Zepbound, approximately 50% lower than the list price.
Price Action: LLY shares are up 1.99% at $611.84 on the last check Wednesday.
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