NSEPress Release1d ago · 30 Oct 2026, 08:05 am

Press Release

Sun Pharmaceutical Industries Limited · SUNPHARMA

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Sun Pharmaceutical Industries Limited has announced that the U.S. FDA has approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis, expanding the use of ILUMYA beyond moderate-to-severe plaque psoriasis.

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Sun Pharmaceutical Industries Limited has informed the Exchange regarding a press release dated October 30, 2026, titled "ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis".

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SUNSEC_30102026080437_SE_Intimation_of_Press_Release_ILUMYA_PsA_Approval.pdf

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Sun Pharmaceutical Industries Limited Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai – 400 063, Maharashtra, INDIA. Tel.: (91-22) 4324 4324 Fax: (91-22) 4324 4343 Website: www.sunpharma.com Email: secretarial@sunpharma.com CIN: L24230GJ1993PLC019050 30 October 2026 National Stock Exchange of India Limited BSE Limited Scrip Symbol: SUNPHARMA Scrip Code: 524715 Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – Press Release Enclosed herewith is a copy of the press release titled “ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis” which shall be released after this intimation. For Sun Pharmaceutical Industries Limited (Anoop Deshpande) Company Secretary and Compliance Officer ICSI Membership No.: A23983 Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA. Reaching People. Touching Lives. Sun Pharmaceutical Industries, Inc. Sun House, Plot No. 201 B/1, Western Express Highway Goregaon (E) Mumbai – 400 063, Maharashtra, INDIA Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 Website : www.sunpharma.com Email : secretarial@sunpharma.com CIN : L24230GL1883PLC019050 FOR IMMEDIATE RELEASE ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis IL-23 inhibitor approved exclusively for healthcare provider-administered treatment Expands use of ILUMYA beyond moderate-to-severe plaque psoriasis strengthening Sun Pharma’s portfolio in psoriatic disease MUMBAI, INDIA and PRINCETON, NJ, (October 30, 2026) – 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 today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ILUMYA® (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA). "FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis,” said Rick Ascroft, North America CEO, Sun Pharma. "As an IL-23 inhibitor administered exclusively by a healthcare provider, ILUMYA is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care." Approximately 2.4 million Americans live with psoriatic arthritis, which can cause joint pain, swelling and stiffness that may lead to permanent joint damage. The approval expands the use of ILUMYA, an IL-23 inhibitor approved by the FDA in 2018 for the treatment of adults with moderate- to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. "Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualize care based on each patient’s symptoms and treatment goals. Adding an IL-23 inhibitor option that is administered by a healthcare provider gives us a new way to offer appropriate patients additional support and engagement with their healthcare team,” said Philip Mease, Director of Rheumatology Research at the Swedish Medical Center and Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine, Seattle, WA. The approval is supported by Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA after only two doses at 24 weeks in adult patients with active psoriatic arthritis. Safety data in the studies was consistent with the well-documented safety profile of ILUMYA. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies. ILUMYA may increase the risk of infection. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment. Most common adverse reactions are: Plaque Psoriasis (≥1%): upper respiratory infections, injection site reactions, and diarrhea. Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19. About the INSPIRE-1 and INSPIRE-2 Phase 3 Studies INSPIRE-1 and INSPIRE-2 are 52-week, global, multicenter, randomized, double-blind, placebo- controlled Phase 3 studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis. Learn more about the studies at clinicaltrials.gov (INSPIRE-1 NCT04314544 and INSPIRE-2 NCT04314531). About Psoriatic Arthritis (PsA) 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 About ILUMYA® (tildrakizumab-asmn) 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 and for the treatment of adults with active psoriatic arthritis, 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. ILUMYA is the 1st biologic to earn the National Psoriasis Foundation (NPF) Seal of Recognition. The NPF Seal recognizes products that meet the Foundation’s established review criteria and reflects Sun’s continued commitment to supporting people living with psoriatic disease. INDICATION ILUMYA® is indicated for the treatment of: • moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. • active psoriatic arthritis in adult patients. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ILUMYA is contraindicated in patients with a history of serious hypersensitivity reaction to tildrakizumab or to any of the excipients. Reaching People. Touching Lives 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 any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA. Instruct patients 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, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves. 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. Monitor patients for signs and symptoms of active TB during and after ILUMYA tre [Showing first 8,000 characters — download PDF for full document]