In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday, the Indianapolis-based company scored FDA approval for its GIP/GLP-1 compound tirzepatide to treat obesity, which will allow broader access to the treatment in the U.S. Dubbed Zepbound, Lilly’s new product is the same formula as blockbuster Type 2 diabetes drug Mounjaro. Since it was endorsed by the FDA in May 2022, Mounjaro has gained widespread, off-label use to treat obesity. Now, Zepbound has been indicated for adults with a BMI of 30 or higher as well as those with a BMI of 27 or higher with weight-related problems such as hypertension, Type 2 diabetes, sleep apnea or cardiovascular disease. With the FDA nod, Lilly now has its answer to Novo’s blockbuster duo of Ozempic for diabetes and Wegovy for obesity. The Danish company gained FDA green lights ...
Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less. By FRANK VINLUAN A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right. Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year. The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision ...
Amidst the rapidly growing revenue share of metabolic disease drugs in its pipeline, Eli Lilly is looking to delve deeper into its pharmaceutical exploration of obesity therapeutics, said medical director Axel Haupt. Haupt was speaking at a panel at the ongoing Bio-Europe 2023 conference, where he said drugs like Lilly’s Mounjaro (tirzepatide) carry potential to be used in for several conditions. The US Food and Drug Administration approved Eli Lilly’s Mounjaro for diabetes in May 2022, followed by the European Union in September 2022. The drug is administered via injection in a once-weekly regimen. Haupt revealed that an FDA approval for Mounjaro for treating obesity could be expected within the next 12 months. Obesity and diabetes treatment would likely not be the only use for Mounjaro, given the presence of GIP receptors in other locations like the adipose tissue, Haupt said. Eli Lilly sees potential use for the drug in ...
Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target. By FRANK VINLUAN Eli Lilly signaled its growing interest in genetic medicines for cardiovascular conditions when it partnered with Verve Therapeutics earlier this year, committing to share in development of a preclinical gene-editing therapy addressing a key heart target. The pharmaceutical giant is now adding more cardiovascular disease drug prospects, pledging $250 million to secure the right to opt into development and commercialization of three additional Verve gene-editing therapies for other key targets. This time, however, the cash isn’t going to Verve. Lilly is paying Beam Therapeutics, whose base-editing technology is used in Verve’s experimental genetic medicines. Their original alliance, started in 2019, gave Beam the option to share in the ...
Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024. By FRANK VINLUAN Drug discovery isn’t only about finding new targets. There’s still plenty of opportunity to find better ways to hit targets that are already drugged, according to Tom Miller, CEO of startup Iambic Therapeutics. Understanding how a molecule interacts with a known disease target enables drug hunters to design molecules that could be superior alternatives for patients. Miller notes that a molecule’s ability to bind to a target protein while leaving related proteins unaffected improves its safety. It’s also important to understand how the distribution of a molecule across tissues in the body affect efficacy. Iambic’s drug discovery research employs ...
Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference. Eli Lilly has submitted its Alzheimer’s disease drug candidate for FDA review, and the pharmaceutical giant is now revealing a more complete look at the clinical data supporting an application that could make the therapy the second anti-amyloid antibody to win full regulatory approval. Lilly had previously said its drug, donanemab, led to a 35% slowing in the decline associated with Alzheimer’s. Those results were for patients with intermediate levels of tau, another protein that’s also characteristic of Alzheimer’s progression. In patients with low-to medium-levels of tau, representing an earlier stage of the disease, treatment with the Lilly drug led to a ...
Eli Lilly on Friday said it will acquire Versanis, a privately held obesity drug maker, for up to $1.93 billion to boost the pharmaceutical giant’s weight loss treatment portfolio. Eli Lilly agreed to pay Versanis shareholders in cash, which will consist of an upfront payment and potentially subsequent payments if Versanis achieves certain “development and sales milestones.” Oakland, California-based Versanis, which was founded in 2021 by biotech investment firm Aditum Bio, has one experimental drug for obesity and potentially other conditions. Eli Lilly’s stock price rose 3% on Friday following the announcement. The deal is Eli Lilly’s latest attempt to capitalize on the weight loss industry gold rush, which began last year after Novo Nordisk’s blockbuster injections Wegovy and Ozempic boomed in popularity. An estimated 40% of U.S. adults are obese. Analysts project that the global weight loss drug market could be worth $100 ...
Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week. Patients who took a 12-milligram dose of retatrutide lost 17.5% of their body weight, or 41 pounds, on average after 24 weeks, compared with 1.6% for those who received the placebo. Patients lost 24.2%, or 58 pounds, on average after 48 weeks. Those who took the placebo lost 2.1% of their body weight after that same time period. The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for ...
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