The late-stage results handily beat earlier trials of the company’s diabetes blockbuster Mounjaro, which racked up sales of $23 billion in 2025.
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The “breakthrough” designation is intended to speed development and expedite review by federal regulators, especially for critical diseases.
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A trial of Eli Lilly and Co.’s blockbuster diabetes drug Mounjaro fell short of expectations in one aspect, but the results showed enough cardio benefits to eventually encourage investors.
The findings were released Thursday by the American Society of Clinical Oncology and will be discussed at its annual meeting.
Trial data data showed Lilly’s experimental weight-loss pill worked as well as the Ozempic shot, bringing it one step closer to developing a needle-free alternative to injections.
Lilly has been making the case since August that its tirzepatide-based drugs are now “commercially available,” which the FDA agreed on. But the agency warned that patients and prescribers might still experience “localized supply disruptions.”
Lilly and rival Novo Nordisk have been battling the emerging industry making copies of their top-selling diabetes and weight-loss drugs, a situation without modern precedent.
Lilly said its new option will help millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance.
The longest continuous study of Indianapolis-based Lilly’s drug Zepbound to date included more than 1,000 patients.
About 37 million American have diabetes, which requires close monitoring of blood sugar levels. A doctor said using the unapproved devices could result in inaccurate blood sugar measurements, with potentially devastating consequences.
Among the medications listed as available through LillyDirect Pharmacy Services is Zepbound, the company’s popular new weight loss treatment, which is projected to exceed $2 billion in sales in 2024.
Eli Lilly and Co. will study its blockbuster diabetes drug Mounjaro in combination with an experimental muscle-loss treatment as it searches for ways to help patients maintain muscle while losing weight.
Much of the excitement is due to strong results from Mounjaro, which hit the market in June 2022 as a treatment for Type 2 diabetes and rang up $979.7 million in the quarter.
With the acquisition of Versanis Bio, Lilly is adding another promising treatment to its weight-loss drug pipeline.
Medical experts predict the pills will be popular, especially among people who want to lose weight but are fearful of needles.
Under the agreement, Lilly has agreed to continue its cap on out-of-pocket costs for its users at $35 a month for four years.
The Indianapolis-based drugmaker said it would complete submission of tirzepatide to the U.S. Food and Drug Administration in coming weeks for treatment of obesity and expects regulatory action as early as late 2023.
Novo Nordisk will start slashing some U.S. insulin prices up to 75% next year, following a path set earlier this month by rival Eli Lilly and Co.
California on Thursday announced it will sue the companies that make and promote most of the nation’s insulin, accusing them of scheming to illegally increase the price of the drug.
The Indianapolis-based pharmaceutical company is preparing for one of its most ambitious years in memory for 2023, with plans to advance five new drugs into late-stage clinical studies and move four into regulatory review.
In an amazing resurrection, teplizumab, developed by another company after Lilly trials were a letdown, is one of the hottest new drugs on the market.
In January, the cost of insulin for patients on Medicare will be capped at $35 a month. But that cap doesn’t apply to those with private insurance, which is used by the majority of those in need of insulin.
