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Sun Pharma Announces US FDA Acceptance of Supplemental Biologics License (sBLA) Application for ILUMYA® (tildrakizumab-asmn) for the Treatment of Adults with Active Psoriatic Arthritis
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.
About this update from Sun Pharmaceutical Industries Limited
[{"type":"text","content":"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","length":225,"tagName":"p","attribs":{}},{"type":"text","content":"With 1 in 3 psoriasis patients developing psoriatic arthritis, Sun Pharma remains committed to better serving patients living with psoriatic disease ","length":149,"tagName":"p","attribs":{}},{"type":"text","content":"MUMBAI, India and PRINCETON, N.J., 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.","length":537,"tagName":"p"},{"type":"text","content":""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."","length":480,"tagName":"p"},{"type":"text","content":"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.","length":516,"tagName":"p"},{"type":"text","content":"Since its approval, ILUMYA has supported nearly 140,000 patients worldwide with durable skin clearance and a well-characterized safety profile through 5 year...