Sun Pharma Wins FDA Approval for Ilumya in Active Psoriatic Arthritis

Sun Pharmaceutical Industries (SUNPHARMA.BO ) announced on October 30, 2026 that the U.S. Food and Drug Administration approved the supplemental Biologics License Application for Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis. The approval, set out in the company’s announcement, expands the IL-23 inhibitor beyond moderate-to-severe plaque psoriasis, the indication for which the FDA first approved the drug in 2018 in adults who are candidates for systemic therapy or phototherapy.

Sun Pharma described Ilumya as an IL-23 inhibitor approved exclusively for administration by a healthcare provider. “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,” said Rick Ascroft, North America CEO of Sun Pharma. Ascroft said the approval represents another important innovative medicine milestone for the company and builds on the established clinical experience of Ilumya in plaque psoriasis.

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 in Seattle, said psoriatic arthritis is a complex and chronic disease and that clinicians need a range of therapeutic options 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,” Mease said.

Approximately 2.4 million Americans live with psoriatic arthritis, which can cause joint pain, swelling and stiffness that may lead to permanent joint damage, according to the announcement. The company stated that roughly 1 in 3 people living with psoriasis also have psoriatic arthritis, typically with psoriasis developing first, and that more than 15 percent of people living with psoriasis may have undiagnosed psoriatic arthritis. The chronic immune-related disease causes swelling, pain and stiffness in joints and entheses, the places where tendons and ligaments connect to bones, and it can develop at any age and regardless of the severity of a patient’s psoriasis.

INSPIRE-1 and INSPIRE-2 Phase 3 Studies

The approval is supported by the Phase 3 INSPIRE-1 and INSPIRE-2 studies, which evaluated the efficacy and safety of Ilumya after only two doses at 24 weeks in adults with active psoriatic arthritis. The studies, registered as NCT04314544 and NCT04314531, are 52-week, global, multicenter, randomized, double-blind, placebo-controlled trials evaluating tildrakizumab 100 mg.

Sun Pharma reported top-line results on July 21, 2025: both studies met their primary endpoint, with a higher proportion of tildrakizumab-treated patients achieving ACR20 responses at Week 24 than patients receiving placebo (p < 0.05). INSPIRE-1 enrolled patients with prior exposure to an anti-TNF agent, while INSPIRE-2 enrolled anti-TNF-naive patients, and more than 800 adults were enrolled across clinical sites in the United States, Europe and Asia.

Tildrakizumab 100 mg was administered at Week 0 and then every 12 weeks, with no induction dose, and participants were permitted to continue concomitant methotrexate or leflunomide provided the dose remained stable throughout the trial. In the Phase 3 studies for chronic plaque psoriasis, dosing included Week 0, Week 4 and then every 12 weeks thereafter, according to the July 2025 release.

The primary endpoint for both studies was the proportion of participants achieving an ACR20 response at Week 24. ACR20 is a composite measure defined as a 20 percent improvement in both the number of tender and the number of swollen joints and a 20 percent improvement in three of five criteria: patient global assessment, physician global assessment, a functional ability measure (most often HAQ-DI), a visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein. ACR50 and ACR70 apply the same measure at improvement levels of 50 percent and 70 percent. Key secondary efficacy endpoints at 24 weeks included ACR50, ACR70 and PASI75. Sun Pharma said in July 2025 that the findings would be presented at upcoming medical conferences and published in a peer-reviewed medical journal.

Safety Profile and Labeling

Sun Pharma stated that safety data in the studies was consistent with the well-documented safety profile of Ilumya and that no new safety signals were identified in INSPIRE-1 and INSPIRE-2. The most common adverse reactions in psoriatic arthritis, occurring in at least 3 percent of patients, were upper respiratory tract infections and COVID-19. In plaque psoriasis, the most common adverse reactions, occurring in at least 1 percent, were upper respiratory infections, injection site reactions and diarrhea.

The labeling warns that Ilumya may increase the risk of infection and states that treatment should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. It directs evaluation of patients for tuberculosis infection before treatment begins, states that Ilumya should not be administered to patients with active tuberculosis, and calls for treatment of latent tuberculosis before Ilumya is given. The label also advises avoiding live vaccines in treated patients and considering completion of age-appropriate immunizations before therapy. Ilumya is contraindicated in patients with a history of serious hypersensitivity reaction to tildrakizumab or any of its excipients; cases of angioedema and urticaria occurred in Ilumya-treated subjects in clinical trials, and the label directs immediate discontinuation if a serious allergic reaction occurs.

The FDA accepted the sBLA for review in March 2026, with a regulatory action date expected by October 29, 2026, Sun Pharma said in a March 16, 2026 release. The company said in that release that supplemental applications for scalp and nail plaque psoriasis were approved in April 2024 and December 2025 respectively, that Ilumya had received marketing authorization from more than 55 health authorities, and that the product had supported nearly 140,000 patients worldwide since its original approval.

Ilumya is a humanized IgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. With the new indication, the U.S. label covers moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy as well as active psoriatic arthritis in adults. Ilumya is also approved for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan, and it is marketed in Europe under the brand name Ilumetri by Almirall. According to Sun Pharma, Ilumya is the first biologic to earn the National Psoriasis Foundation Seal of Recognition, which recognizes products that meet the foundation’s established review criteria.