Tildrakizumab-ASMN

DENVER--(BUSINESS WIRE)--Almirall S.A. (ALM), a global biopharmaceutical company dedicated to medical dermatology, is presenting a broad range of clinical and real‑world data across its portfolio at the 2026 American Academy of Dermatology (AAD) Annual Meeting. The company’s presence includes more than 15 scientific posters, led by 9 lebrikizumab presentations in atopic dermatitis (AD), new analyses on tirbanibulin (AK), two on tildrakizumab from the POSITIVE study, and two sarecycline pooled Phase 3 evaluations in acne. "Our goal is to bring meaningful, evidence‑based treatment options to people living with skin diseases. The breadth of data we are sharing at AAD 2026 – from long‑term results and real‑world evidence for lebrikizumab to clinically relevant AK endpoints with tirbanibulin – reflects our commitment to rigorous science, patient‑centred outcomes, and strong collaboration with dermatology partners,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. “AAD is an important moment each year to demonstrate our dedication to advancing medical dermatology and patient care. The new data we are sharing underline the real progress made across multiple skin diseases, and our commitment to bringing dermatologists evidence that supports better decision‑making and better care for their patients,” said Paul Rittman, President & General Manager, Almirall U.S. Almirall’s presence at AAD 2026 is an important opportunity to connect with healthcare professionals, partners, and industry peers. AAD 2026 is a leading international forum for medical dermatology expertise and collaboration and takes place March 27–31 in Denver, Colorado. Addressing Unmet Needs in Medical Dermatology Dermatological diseases can exert a profound physical and emotional burden. With a portfolio spanning inflammatory and proliferative skin conditions and an expanding evidence base across both controlled and real‑world settings, Almirall continues to partner with the dermatology community to improve outcomes, experience and long‑term disease control. With over 80 years of experience in healthcare, Almirall is committed to advancing science in dermatology through continuous investment in research and development and by fostering strong partnerships with the medical and scientific communities. The company's expanding portfolio in medical dermatology, particularly its focus on advanced biologic solutions for psoriasis and atopic dermatitis, underscores its dedication to providing innovative dermatological treatments and enhancing patient outcomes. 2026 AAD Annual Meeting poster overview: Almirall and its partners will present more than 15 scientific posters across atopic dermatitis, psoriasis, actinic keratosis and acne, including: Lebrikizumab (Atopic Dermatitis) – 3 Almirall Posters + 6 Eli Lilly Posters Head, neck and face AD in patients with skin of color (ADmirable) 4 year long-term safety and efficacy (ADlong) Real-world effectiveness and advanced systemic pretreated populations (ADLIFE) Improvements in absolute endpoints in real-world settings (ADLIFE) EASI clinical responses across body regions in patients needing >16 weeks to reach EASI 75/IGA 0–1 Clinical feature improvements in skin of color Allergic rhinitis comorbidity and PREPARED‑1 study design Reasons for initiating lebrikizumab in adolescents with moderate-to-severe AD Exposure–response modelling supporting every 8 week maintenance dosing Tildrakizumab (Psoriasis) – 2 Almirall Posters + 4 Sun Pharma Posters Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis overall and in high-impact areas: 2-year results from the POSITIVE study Beyond skin clearance: Tildrakizumab in moderate-to-severe psoriasis patients – 2-year POSITIVE study results Efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis affecting the nails: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b trial Real-World Tildrakizumab Effectiveness in the US by Biologic Experience and Geographic Region in the PPD CorEvitas Psoriasis Registry Real-World Tildrakizumab Persistence in the US by Biologic Experience and Insurance Coverage in the PPD CorEvitas Psoriasis Registry Regional Differences in Patient Characteristics Among US Biologic Initiators from the PPD CorEvitas Psoriasis Registry Tirbanibulin (Actinic Keratosis) – 3 Posters Efficacy beyond complete clearance: percent lesion reduction as a meaningful endpoint Efficacy, safety and tolerability of up to two 5-day treatment courses Achieving complete clearance with mild-to-moderate LSRs: pooled Phase III analysis Sarecycline (Acne) – 2 Posters Truncal acne outcomes: multinational pooled Phase 3 analysis Pooled Phase 3 results in moderate-to-severe facial acne About Klisyri (tirbanibulin) ointment, 1%: INDICATION KLISYRI is a microtubule inhibitor indicated for the topical field treatment of actinic keratosis on the face or scalp. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Ophthalmic Adverse Reactions Klisyri may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible. Local Skin Reactions Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of Klisyri. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of Klisyri is more likely to result in irritation. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain. Click here to view: Full Prescribing Information About Seysara (sarecycline) tablets: INDICATIONS AND USAGE SEYSARA (sarecycline) tablet 60/100/150 mg, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use: Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS AND PRECAUTIONS Like other tetracyclines, SEYSARA can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy, or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately. The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. Central nervous system side effects , including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and papilledema. Although signs and symptoms of intracranial hypertension resolve after discontinuation of treatment, the possibility for sequelae such as visual loss that may be permanent or severe exists. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA. Bacterial resistance to tetracyclines may develop in patients using SEYSARA. Because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, it should only be used as indicated. As with other antibiotic preparations, use of SEYSARA may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted. ADVERSE REACTIONS The most common adverse reaction (incidence ≥1%) was nausea: SEYSARA 3.1% vs placebo 2.0%. Please see full Prescribing Information. About Ilumya (tildrakizumab-asmn): INDICATION AND IMPORTANT SAFETY INFORMATION ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. Please see full Prescribing Information. About Ebglyss (lebrikizumab-lbkz): INDICATION AND SAFETY SUMMARY EBGLYSS is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids. It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients. Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you: Have a parasitic (helminth) infection. Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS. Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy. Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Possible side effects EBGLYSS can cause serious side effects, including: Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. The most common side effects of EBGLYSS include: eye and eyelid inflammation, including redness, swelling, and itching injection site reactions shingles (herpes zoster) These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. How to take Use EBGLYSS exactly as prescribed by your healthcare provider. EBGLYSS is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver. If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time. Learn more EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you. Content addressed for US audience only. About Almirall Almirall is a global biopharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit https://www.almirall.com/

If the sBLA is approved, expansion into psoriatic arthritis would build on the established clinical experience of ILUMYA as an IL-23 inhibitor for moderate-to-severe plaque psoriasis; FDA decision expected by October 29, 2026 With 1 in 3 psoriasis patients developing psoriatic arthritis, Sun Pharma remains committed to better serving patients living with psoriatic disease March 16, 2026 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associated companies) announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis. The FDA regulatory action date for this sBLA is expected by October 29, 2026. "For many people living with psoriatic disease, joint symptoms often add another layer of burden," says Rick Ascroft, CEO, Sun Pharma North America. "As we continue to strengthen Sun Pharma's innovative portfolio, we look forward to working with the FDA throughout the review process. As the only HCP-administered IL-23 biologic, our ambition is that ILUMYA becomes a differentiated first-choice advanced systemic treatment for active psoriatic arthritis." If approved, this would mark a new indication for ILUMYA following its US FDA approval in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Scalp and nail plaque psoriasis sBLAs were approved in April 2024, and December 2025, respectively. ILUMYA has also received marketing authorization from over 55 worldwide health authorities since its original approval, including in India, Japan, the European Union, China, Australia and Canada. Since its approval, ILUMYA has supported nearly 140,000 patients worldwide with durable skin clearance and a well-characterized safety profile through 5 years of clinical follow-up. Additionally, real-world experience has shown strong adherence and persistence, helping patients stay on treatment long-term. ILUMYA has been endorsed widely by dermatologists in the US and globally as a trusted and effective treatment for adults with moderate-to-severe plaque psoriasis. The sBLA is based on the results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies evaluating the efficacy and safety of ILUMYA in adult patients with active psoriatic arthritis. Top-line findings from these studies were reported in July 2025. Further details of the studies will be shared at a future congress. Sun Pharma appreciates the tireless contributions of the participating clinical sites and the participants involved in the PsA investigational clinical trial program. ILUMYA may cause serious side effects, including serious allergic reactions. Do not take ILUMYA if allergic to it. Seek emergency medical help right away for an allergic reaction. ILUMYA may increase risk of infections and lower ability to fight them. Call a doctor about any infection. Before starting, a doctor will check for infections and tuberculosis (TB). Consult a doctor before vaccinations; avoid live vaccines. Most common side effects are upper respiratory infections, injection site reactions, and diarrhea. The INSPIRE-1 and INSPIRE-2 are both 52-week global, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies aimed at assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA®) in adult patients with active psoriatic arthritis. Psoriatic arthritis (PsA) is a chronic (long-lasting or recurring) disease related to the immune system. It causes swelling, pain, and stiffness in joints and entheses (places where tendons and ligaments connect to bones).1 Psoriatic arthritis can develop at any age.2 Psoriatic arthritis can occur regardless of the severity of psoriasis (mild, moderate, or severe). Roughly 1 in 3 people living with psoriasis also have psoriatic arthritis3; typically, with psoriasis developing before psoriatic arthritis.2 While as many as 2.4 million Americans live with psoriatic arthritis, more than 15% of people living with psoriasis may also have undiagnosed psoriatic arthritis.4 ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan, and under the brand name ILUMETRI® in Europe, where it is marketed by Almirall. Sun Pharma is the world's leading specialty generics company with a presence in innovative medicines, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global Emerging Markets. Sun Pharma's high-growth global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. References National Psoriasis Foundation. About Psoriatic Arthritis. Available at Psoriatic Arthritis: Symptoms, Causes & Treatment. Accessed February 2026. Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis [published correction appears in N Engl J Med. 2017 May 25;376(21):2097]. N Engl J Med. 2017;376(10):957-970. doi:10.1056/NEJMra1505557 Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729-735. doi:10.1016/j.jaad.2013.07.023 Villani AP, Rouzaud M, Sevrain M, et al. Prevalence of undiagnosed psoriatic arthritis among psoriasis patients: Systematic review and meta-analysis. J Am Acad Dermatol. 2015;73(2):242-248. doi:10.1016/j.jaad.2015.05.00 The content above comes from the network. if any infringement, please contact us to modify.