Dermira, Inc.

With an FDA approval in atopic dermatitis for Ebglyss, Eli Lilly hopes to challenge Regeneron and Sanofi's Dupixent, which is dominant in the indication. Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss to treat atopic dermatitis (AD).The endorsement covers adults and patients between the ages of 12 and 18 who weigh at least 88 pounds. It is for those who have a moderate-to-severe form of the disease and don't achieve an adequate response with prescription topical treatments. The company said it plans to launch Ebglyss, also known as lebrikizumab, in the coming weeks but is not yet divulging its price in the U.S.The nod comes on top of Lilly expanding its label for JAK inhibitor Olumiant in 2022 as the first systemic medicine to treat alopecia areata and gaining approval in October of last year for IL-23 ulcerative colitis therapy Omvoh. In 2022, Lilly’s then chief of its immunology unit, Patrik Jonsson, said that the company was making a “long-term commitment” to immunology for the “coming decade or decades.”As part of the push in 2020, Lilly acquired lebrikizumab when it bought out California-based Dermira for $1.1 billion.The approval for Ebglyss comes a year late. The FDA rejected it in October, citing findings from an inspection of a third-party manufacturer. The agency’s complete response letter (CRL) did not raise any issues with lebrikizumab’s clinical data package, label or safety.Earlier this year, Japan and Canada signed off on Ebglyss. It was approved last year in Europe, where Spain’s Almirall has licensed the rights to develop and commercialize it for dermatology indications. “Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,” Jonathan Silverberg, M.D., Ph.D., professor of dermatology at George Washington University School of Medicine and Health Sciences, said in a release.Ebglyss is dosed monthly with a 250 mg injection after an introductory regimen, which includes 250 mg injections two weeks apart until adequate clinical response is achieved. It can be used along with topical corticosteroids. Three trials, which included more than 1,000 patients, backed the approval of Ebglyss. In the ADvocate 1 and 2 studies, an average of 38% of those who took Ebglyss had clear or almost-clear skin after 16 weeks, versus 12% on placebo. Of those who achieved that standard, 77% retained those results with maintenance dosing for a year. Of those Ebglyss responders who switched to placebo at Week 16, 48% maintained their results for a year.Lilly hopes to challenge Regeneron and Sanofi’s dominant IL-4/IL-13 treatment in the indication, Dupixent. Another IL-13 on the market for AD is Leo Pharma’s Adbry, which was launched in 2022.   

Atopic dermatitis is treatable with many drugs currently on the market, but many patients find these therapies lacking. The FDA has approved an Eli Lilly drug that offers a new biologic treatment option with a dosing schedule that’s less burdensome for patients. The regulatory decision announced late Friday covers the treatment of adults and children age 12 and older with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription drugs. The Lilly drug, lebrikizumab, will be marketed as Ebglyss, which is the same brand name for the product in Europe and Japan where it has already been approved. The excessive immune response in atopic dermatitis, also known as eczema, leads to skin that’s dry, itchy, and inflamed. More than 16 million adults in the U.S. have eczema, and 6.6 million of these patients experience moderate-to-severe symptoms, according to the National Eczema Association. Topical steroids are a standard treatment, but many patients find these anti-inflammatory therapies do not sufficiently control symptoms. Lilly’s Ebglyss takes a different approach. The drug is an antibody designed to target and block IL-13, a signaling protein associated with the inflammation that drives atopic dermatitis. The injectable drug was initially developed by skin disease biotech Dermira, which Lilly acquired for $1.1 billion in 2020. Sponsored Post What Healthcare Can Learn from Costco The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion. By Jeff Bak, Imagine360 CEO and President Drugs that target IL-13 to treat atopic dermatitis are already available. This disease was the first indication for Sanofi and Regeneron Pharmaceuticals drug Dupixent, which won its first FDA approval in 2017. The biologic medicine has since become a blockbuster product with approvals in several autoimmune disorders (the FDA on Friday approved Dupixent for chronic rhinosinusitis with nasal polyps). Dupixent is an antibody engineered to block two signaling pathways, IL-13 and IL-14. LEO Pharma’s Adbry, an antibody designed to block IL-13, won FDA approval in atopic dermatitis in 2021. Dupixent and Adbry are administered as every-other week injections following initial dosing. Lilly’s Ebglyss offers patients its IL-13-blocking effects with once-monthly maintenance dosing. FDA approval of Ebglyss is based on results from two Phase 3 studies that showed 38% of participants who received the study drug achieved clear or almost-clear skin at 16 weeks. By comparison, 12% of those in the placebo arm achieved that mark at 16 weeks. Of those who experienced clear or almost-clear skin at week 16, 77% maintained these results at one year with once-monthly dosing. Study results also showed itch relief. On average, 43% of participants who took Ebglyss felt itch relief at 16 weeks compared to 12% of those who were given a placebo, Lilly said. Of those people who felt itch relief at week 16, 85% still felt that relief at one year with once-monthly maintenance dosing. The most common side effects reported in the studies included eye and eyelid inflammation, injection site reactions, and shingles. According to Jonathan Silverberg, professor of dermatology at George Washington University School of Medicine and Health Sciences and first author of the Ebglyss clinical trial results published last year in The New England Journal of Medicine, patients still struggle to control moderate-to-severe atopic dermatitis with currently available therapies. “Today’s FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough,” Silverberg said in Lilly’s announcement of the drug’s approval. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani The FDA nod for Ebglyss comes later than Lilly initially expected. Last October, the FDA turned down Lilly’s submission for the drug citing problems with the product’s third-party manufacturer. No issues were raised about clinical data or safety. The European Commission approved Ebglyss last November. Barcelona-based Alimirall licensed European rights to Ebglyss; Lilly retains rights to the drug in the rest of the world. Regulators in Japan approved Ebglyss early this year. Lilly expects regulatory decisions for the drug in other markets later this year. The company said Ebglyss will become available in the U.S. in coming weeks.

Almirall expects EBITDA of between €175m and €190m this year. Image credit: Shutterstock/ T. Schneider. Almirall has reported a 6.7% increase in total net sales for the first half of 2024, with the company’s European dermatology business spurring much of the company’s revenue streams. Almirall generated a total of €497.2m ($541.4m) in H1 this year, a year-over-year (YOY) sales increase of 3.2%. The results meant the Spanish pharma reiterated its growth guidance for 2024, estimating an EBITDA of between €175m and €190m, as per a 22 July press release. Shares in the company opened 3.9% higher based on the financial results. Almirall has a €2bn market cap. Almirall’s dermatology business in Europe was the engine for much of the company’s growth, propped up by higher sales of the psoriasis treatment Ilumetri (tildrakizumab) and the recent launch of Ebglyss (lebrikizumab) for atopic dermatitis. In an earnings call on 22 July, Almirall CEO Carlos Gallardo said: “It’s still early days, but we are very encouraged by the strong progress of the product sales [for Ebgylss].” See Also: Rusan Pharma’s API Plant in Ankleshwar Receives USFDA GMP Approval UK MHRA approves Lupin and Zentiva’s raltegravir for HIV Gallardo added that the company expects to “capture a significant share of the advanced therapies market in atopic dermatitis”. Ilumetri, an anti-interleukin-23 (IL-23) antibody, is Almirall’s best-selling product. The drug reached over €100m in sales in H1 this year, representing a 25% increase compared to the same period in 2023. Almirall said it forecasts €250m in peak sales for the drug in 2024. Ilumetri is the European brand name for Ilumya – Almirall having licensed European rights for the drug from Sun Pharma in 2016. European sales for the drug are estimated to reach $300m by 2030, whilst US sales are expected to soar past $1.2bn by the same year, according to analysis by GlobalData. GlobalData is the parent company of Pharmaceutical Technology. Ebgylss meanwhile was recently launched in Germany, the UK, and Norway, and was recommended by England’s National Institute for Health and Care Excellence ( Nice ) for use on the NHS last month. Further rollouts in Denmark, Spain, and Austria are expected later this year for the drug. Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Globally, Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. Unlike its European counterpart, Almirall’s US dermatology business sales decreased by 4.1%, though CFO Mike McClellan said the business is showing “nearly stable results”, but it is under pressure from “ongoing generic erosion” in the country.