Sun Pharma announces FDA acceptance of sBLA for ILUMYA for psoriatic arthritis
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.
The company said that if approved, the application would add a new indication for ILUMYA. The therapy was approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Supplemental approvals for scalp and nail plaque psoriasis were granted 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.
Rick Ascroft, CEO, Sun Pharma North America, said, ?For many people living with psoriatic disease, joint symptoms often add another layer of burden. ?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 HHCP-administeredIL-23 biologic, our ambition is that ILUMYA becomes a differentiated first-choice advanced systemic treatment for active psoriatic arthritis.?
Sun Pharmaceutical Industries is engaged in the business of manufacturing, developing and marketing a wide range of branded and generic formulations and active pharmaceutical ingredients (APIs). The company and its subsidiaries has various manufacturing facilities spread across the world with trading and other incidental and related activities extending to global market. It is the largest pharmaceutical company in India.
The company has reported a 16.03% rise in consolidated net profit to Rs 3,368.81 crore on a 13.49% increase in revenue to Rs 15,520.54 crore in Q3 FY26 over Q3 FY25.
The counter rose 0.37% to Rs 1,789.15 on the BSE.
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