Sun Pharma Secures US FDA Approval for ILUMYA to Treat Active Psoriatic Arthritis

Sun Pharmaceutical Industries Limited has received approval from the United States Food and Drug Administration (US FDA) for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis, expanding the medicine’s approved applications beyond moderate-to-severe plaque psoriasis. The approval, announced on 30 October 2026, follows the regulatory review of a supplemental Biologics License Application supported by clinical evidence from two Phase 3 studies.

The approval represents an important development in Sun Pharma’s innovative medicines portfolio, particularly in the treatment of chronic inflammatory conditions. ILUMYA is an interleukin-23 (IL-23) inhibitor administered exclusively by healthcare professionals, providing an additional treatment option for adults living with active psoriatic arthritis. According to the company, the new indication builds upon the medicine’s established clinical experience in treating plaque psoriasis.

US FDA Expands ILUMYA’s Approved Indications

The US FDA approved Sun Pharma’s supplemental Biologics License Application for ILUMYA, allowing the medicine to be used in adults diagnosed with active psoriatic arthritis. The treatment was originally approved in the United States in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis is a chronic immune-mediated inflammatory disease that can affect the joints, surrounding tissues and other parts of the musculoskeletal system. The condition is associated with joint pain, swelling and stiffness, while persistent inflammation may contribute to permanent joint damage in some patients.

According to Sun Pharma, approximately 2.4 million people in the United States live with psoriatic arthritis. The condition can create considerable difficulties in everyday activities because of pain, impaired mobility and the progressive nature of joint inflammation.

The expanded approval enables healthcare professionals to consider ILUMYA as another treatment option for appropriate adult patients, subject to the medicine’s approved prescribing information and individual clinical requirements.

Phase 3 INSPIRE-1 and INSPIRE-2 Studies Support Approval

The regulatory approval was supported by results from the Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA in adults with active psoriatic arthritis.

Both studies assessed treatment outcomes at Week 24 after patients had received two doses of the medicine. The trials evaluated improvements in the signs and symptoms of psoriatic arthritis using established clinical assessment methods.

According to Sun Pharma, both studies achieved their primary endpoints, with patients receiving tildrakizumab demonstrating statistically significant improvements compared with those receiving placebo.

The primary endpoint involved the American College of Rheumatology 20% response criterion, commonly known as ACR20. This measure assesses improvement in tender and swollen joint counts together with other indicators of disease activity, pain and physical functioning.

The company reported that a significantly higher proportion of patients receiving ILUMYA achieved ACR20 responses at Week 24 compared with participants in the placebo groups. These findings formed an important part of the clinical evidence submitted for regulatory review.

ILUMYA Targets Interleukin-23 Inflammatory Pathway

ILUMYA contains tildrakizumab-asmn, a humanised monoclonal antibody designed to selectively inhibit the p19 subunit of interleukin-23.

Interleukin-23 is a signalling protein involved in immune-system activity and inflammatory pathways associated with psoriasis and psoriatic arthritis. By targeting this pathway, tildrakizumab is intended to reduce inflammatory activity associated with these conditions.

The medicine belongs to a class of biological therapies that target specific components of the immune system rather than acting through broader anti-inflammatory mechanisms.

ILUMYA is administered by subcutaneous injection under the supervision of a healthcare professional. Sun Pharma has highlighted healthcare provider administration as a feature of the treatment, particularly for patients who may be unable to self-administer biological medicines or who may benefit from regular clinical supervision.

Treatment decisions depend on the patient’s medical history, disease activity, previous therapies and other clinical considerations.

Safety Profile Evaluated During Clinical Trials

Sun Pharma stated that the safety findings from the INSPIRE-1 and INSPIRE-2 studies were consistent with the established safety profile of ILUMYA, with no new safety signals identified during the trials.

However, ILUMYA affects immune-system activity and may increase the risk of infections. Patients must therefore undergo appropriate medical assessment before beginning treatment, including evaluation for tuberculosis infection.

The company identified upper respiratory tract infections and COVID-19 among the commonly reported adverse reactions in patients treated for psoriatic arthritis.

As with other biological therapies affecting immune responses, prescribing physicians must consider the medicine’s warnings, contraindications and precautions before initiating treatment.

The FDA’s approval applies specifically to the authorised indication and does not mean the medicine is suitable for every patient with psoriatic arthritis.

Approval Builds on ILUMYA’s Existing Clinical Applications

ILUMYA has been part of Sun Pharma’s innovative medicines portfolio since receiving its original US FDA approval for moderate-to-severe plaque psoriasis in 2018.

The medicine subsequently received additional approvals involving scalp psoriasis in 2024 and nail psoriasis in 2025, extending its authorised applications within the treatment of psoriatic disease.

The latest approval for active psoriatic arthritis broadens its role beyond skin manifestations to include an inflammatory condition affecting the joints and other musculoskeletal structures.

According to Sun Pharma, ILUMYA has received marketing authorisations from more than 55 regulatory authorities worldwide since its initial approval. These include authorities in India, Japan, the European Union, China, Australia and Canada.

The company has also reported substantial clinical experience with ILUMYA in plaque psoriasis treatment, supported by long-term follow-up data and real-world treatment experience.

Sun Pharma Strengthens Innovative Medicines Portfolio

Sun Pharmaceutical Industries is one of India’s major pharmaceutical companies, with operations spanning generic medicines, specialty pharmaceuticals, active pharmaceutical ingredients and innovative therapies.

The company has been expanding its portfolio of specialty medicines, including treatments for dermatological and immunological conditions.

The approval of ILUMYA for active psoriatic arthritis represents another regulatory milestone in this segment, extending the medicine’s authorised therapeutic applications in the United States.

The company’s clinical development programme for ILUMYA included the Phase 3 INSPIRE studies, which generated evidence supporting the regulatory submission for the additional indication.

The latest approval follows the US FDA’s acceptance of the supplemental Biologics License Application for review in March 2026, completing an important stage of the regulatory process.

Expanding Treatment Options for Patients with Psoriatic Disease

Sun Pharma has emphasised the importance of developing additional treatment options for people living with chronic inflammatory diseases, including patients whose conditions affect both the skin and joints.

Commenting on the approval, Rick Ascroft, Chief Executive Officer of Sun Pharma North America, described the decision as an important milestone for the company’s innovative medicines business and its established clinical experience with ILUMYA in plaque psoriasis.

He highlighted that the medicine’s healthcare provider-administered approach offers an additional option for adults with active psoriatic arthritis who may benefit from regular in-office treatment.

The company has stated that the expanded approval strengthens its commitment to addressing the medical needs of people living with psoriatic disease.

With the US FDA’s approval of ILUMYA for active psoriatic arthritis, Sun Pharmaceutical Industries has achieved another milestone in its innovative medicines programme, expanding the treatment’s approved applications and providing healthcare professionals with an additional therapeutic option for adults affected by this chronic inflammatory condition.

---