Eli Lilly and Company (LLY) announced that the FDA has granted approval to its IL-13 inhibitor Ebglyss (lebrikizumab) for treating moderate-to-severe atopic dermatitis, also called eczema. Ebglyss is approved for use in adults and children aged 12 and above who weigh at least 40 kgs and whose moderate-to-severe atopic dermatitis is not well controlled with topical prescription medicines.Ebglyss was approved in the European Union in 2023 and in Japan in January this year. The drug generated sales of $7.5 mil ...

EBGLYSS Approval and Efficacy - EBGLYSS, a targeted IL-13 inhibitor, has been approved by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults and children aged 12 and older who weigh at least 40 kg [1] - Patients treated with EBGLYSS experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks [1] - In clinical trials, 38% of patients achieved clear or almost-clear skin at 16 weeks, compared to 12% with placebo, and 77% maintained these results at one year with monthly dosing [3] - 43% of patients experienced itch relief at 16 weeks, compared to 12% with placebo, and 85% maintained this relief at one year with monthly dosing [3] EBGLYSS Dosing and Administration - EBGLYSS is administered as a 250 mg/2 mL injection, with an initial dose of 500 mg at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16, then a single monthly maintenance dose [2] - The drug can be used with or without topical corticosteroids [2] Clinical Trials and Study Results - The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 patients with moderate-to-severe eczema [3] - The primary endpoint was clear or almost-clear skin (IGA 0,1) at 16 weeks, with key secondary endpoints including Eczema Area and Severity Index (EASI) and Pruritus Numeric Rating Scale [6][7] Market and Commercialization - EBGLYSS was approved by the European Commission in 2023 and in Japan in January 2024, with additional markets expected later this year [5] - Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe, while Almirall S.A. holds rights in Europe [5] Patient Impact and Market Potential - Nearly 16.5 million adults in the U.S. have eczema, with 6.6 million experiencing moderate-to-severe symptoms [3] - EBGLYSS offers a new first-line biologic treatment option for patients who do not respond well to topical therapies [3] Mechanism of Action - EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13, a cytokine implicated in the pathophysiology of eczema [15] - The drug binds to IL-13 at an area overlapping with the IL-4Rα subunit, preventing receptor complex formation and inhibiting IL-13 signaling [15] Future Developments - Further data results from the ADmirable and ADapt studies are expected to be shared in 2024 and early 2025 [15]

The drug giant's winning ways look set to continue for a while.It's hard not to admire what Eli Lilly (LLY 1.53%) has accomplished over the past five years. The drugmaker has been riding a wave of strong financial results and excellent regulatory progress to become the largest healthcare company by market capitalization. It's inching closer to a $1 trillion valuation -- and at the rate it has been going, don't be surprised if it hits that milestone within a year.However, despite the terrific gains Eli Lilly ...

Key TakeawaysEli Lilly is investing $1.8 billion to expand production in Ireland of its Alzheimer's treatment and weight-loss drugs.The company's Alzheimer's drug, Kisunla, was approved by the U.S. Food and Drug Administration last month.Eli Lilly has committed more than $20 billion to manufacturing investments in the U.S. and Europe since 2020. Eli Lilly (LLY) said Thursday it will spend $1.8 billion to expand production in Ireland of its popular diabetes and weight-loss drugs, as well as some active ingre ...

Large drug-maker stocks have witnessed a strong run this year, driven by positive pipeline news and regulatory approvals. The FDA has granted approval to 29 novel drugs this year. Innovation in the industry is at its peak, with spaces like weight loss/obesity, inflammation and Alzheimer’s disease attracting investor interest in 2024.Novel diabetes and obesity drugs of Eli Lilly (LLY) and Novo Nordisk have taken the pharma sector by storm with both Eli Lilly’s tirzepatide drugs (Mounjaro and Zepbound) and No ...

A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.Eli Lilly on Thursday said it will invest $1.8 billion to boost manufacturing for its newly approved Alzheimer's drug and highly popular weight loss and diabetes treatments, among other medicines, in Ireland. The pharmaceutical giant is spending $1 billion to expand an existing site in Limerick, Ireland, to increase the production of certain active ingredients in drugs, including those used ...

There's a little appreciated reason to own Eli Lilly stock, and it has nothing to do with its medicines.Eli Lilly (LLY -0.77%) might just be the hottest pharmaceutical company on the planet right now. The company is the developer of a number of blockbuster drugs including Verzenio, Trulicity, and Taltz.Of course, I'd be remiss to not include the company's latest hits in weight loss. Lilly's diabetes and obesity care medications, Mounjaro and Zepbound, are currently fueling a new wave of growth for the pharm ...

Eli Lilly and Regeneron Pharmaceuticals are good stock-split candidates thanks to years of successes.Stock splits can get the market excited, even though nothing changes for the business fundamentally, including its future prospects. So what's the reason behind a rally following a stock split? Once a company's share price goes above a certain psychological threshold, the average investor begins to perceive the stock as "expensive" and worries about being unable to buy enough (or even whole) shares of that c ...

In QWINT-2, efsitora helped adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists achieve an A1C below 7% Detailed results were published in The New England Journal of Medicine and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024INDIANAPOLIS, Sept. 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the QWINT-2 phase 3 trial evaluating once-weekly insulin efsitora alfa (efsit ...

Eli Lilly has been a big-time winner for investors over the last several decades, and there are many reasons to believe the company is at the forefront of many new growth stories.A couple of months ago, I stumbled across a podcast featuring Palantir co-founder Joe Lonsdale and Home Depot co-founder Ken Langone. During their talk, Lonsdale asked Langone several questions related to his investment philosophy. Initially, I thought these questions were a little bizarre. After all, given Home Depot's success ove ...