FDA approval expands the use of tildrakizumab beyond plaque psoriasis, giving doctors another treatment option for a condition that can cause lasting joint damage

Sun Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) to use its drug ILUMYA® (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. The decision, announced on October 30, 2026, allows the company to offer the medicine for a second condition after its earlier approval for moderate-to-severe plaque psoriasis.

The approval applies to adults with active psoriatic arthritis (PsA), a long-term condition that can cause pain, swelling and stiffness in the joints. In some patients, the disease can lead to permanent joint damage.

Sun Pharma, which is based in Mumbai, said the FDA had approved its supplemental Biologics License Application (sBLA) for ILUMYA. The medicine belongs to a group of drugs known as interleukin-23 (IL-23) inhibitors.

Around 2.4 million Americans live with psoriatic arthritis, according to the company’s announcement. The condition is linked to psoriasis, a disease that causes patches of red, dry and scaly skin. Some people with psoriasis develop joint problems, while others may experience joint symptoms before their skin condition is recognised.

Psoriatic arthritis can affect different parts of the body. Patients may have swollen fingers or toes, pain in the feet and back, and stiffness that makes movement difficult. The condition varies from person to person, so doctors must consider each patient’s symptoms and health needs when choosing treatment.

ILUMYA was first approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic treatment or phototherapy. Systemic treatment works throughout the body, while phototherapy uses controlled exposure to light to treat skin disease.

The new approval allows doctors to prescribe ILUMYA for active psoriatic arthritis. It also gives patients another option when their treatment needs call for a medicine that is administered by a healthcare professional.

Rick Ascroft, North America CEO of Sun Pharma, said: “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.”

The drug is given by injection under the skin and must be administered by a healthcare provider. This may suit some patients who cannot give themselves injections or prefer to receive treatment during a medical visit.

The approval is based on two Phase 3 clinical studies, INSPIRE-1 and INSPIRE-2. Both studies examined the safety and effectiveness of tildrakizumab in adults with active psoriatic arthritis. The trials assessed results at 24 weeks, after patients had received two doses.

Published trial findings reported that 38.8% of patients receiving tildrakizumab achieved an ACR20 response at Week 24, compared with 24.4% of those receiving a placebo. ACR20 is a standard measure used in arthritis studies. It records whether a patient has achieved at least a 20% improvement in several measures of disease activity.

The trials also found improvements in other measures, including joint symptoms and skin disease. The results provide clinical support for the FDA’s decision, although treatment response can vary between patients.

Philip Mease, Director of Rheumatology Research at Swedish Medical Centre 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. As clinicians, we need a range of therapeutic options that allow us to individualise 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 Centre and Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine, Seattle, WA.

The drug’s safety findings in INSPIRE-1 and INSPIRE-2 were consistent with its known safety profile, and no new safety signals were identified in the studies.

However, ILUMYA may increase the risk of infection. Patients must be checked for tuberculosis (TB) infection before starting treatment. The most common adverse reactions reported for plaque psoriasis, affecting at least 1% of patients, include upper respiratory infections, injection site reactions and diarrhoea. For psoriatic arthritis, the most common reactions, affecting at least 3% of patients, include upper respiratory tract infections and COVID-19.

The approval adds another medicine to the range of treatments doctors can consider for psoriatic disease. The choice of treatment depends on the patient’s symptoms, medical history and response to earlier medicines. Patients should discuss the benefits and risks with their healthcare provider before starting treatment.

For Sun Pharma, the US approval extends ILUMYA’s use into another disease area. For people living with active psoriatic arthritis, it means doctors now have an additional FDA-approved treatment option to consider as part of their care.

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