ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis

IL-23 inhibitor approved exclusively for healthcare provider-administered treatment

Expands use of ILUMYA beyond moderate-to-severe plaque psoriasis strengthening Sun Pharma's portfolio in psoriatic disease

MUMBAI, India and PRINCETON, N.J., Oct. 30, 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 today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ILUMYA^® (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA).

"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."

Approximately 2.4 million Americans live with psoriatic arthritis, which can cause joint pain, swelling and stiffness that may lead to permanent joint damage. The approval expands the use of ILUMYA, an IL-23 inhibitor approved by the FDA in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

"Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us 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," said 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, Seattle, WA. 

The approval is supported by Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA after only two doses at 24 weeks in adult patients with active psoriatic arthritis.

Safety data in the studies was consistent with the well-documented safety profile of ILUMYA. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies. ILUMYA may increase the risk of infection. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment. Most common adverse reactions are: Plaque Psoriasis (≥1%): upper respiratory infections, injection site reactions, and diarrhea. Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19.

About the INSPIRE-1 and INSPIRE-2 Phase 3 Studies
INSPIRE-1 and INSPIRE-2 are 52-week, global, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis.

Learn more about the studies at clinicaltrials.gov (INSPIRE-1 NCT04314544 and INSPIRE-2 NCT04314531).

About Psoriatic Arthritis (PsA)
Psoriatic arthritis (PsA) is a chronic (long-lasting or recurring) disease related to the immune system. It causes swelling, pain, and stiffness in joints and entheses (places where tendons and ligaments connect to bones).¹ Psoriatic arthritis can develop at any age.² Psoriatic arthritis can occur regardless of the severity of psoriasis (mild, moderate, or severe). Roughly 1 in 3 people living with psoriasis also have psoriatic arthritis³; typically, with psoriasis developing before psoriatic arthritis.² While as many as 2.4 million Americans live with psoriatic arthritis, more than 15% of people living with psoriasis may also have undiagnosed psoriatic arthritis.⁴

About ILUMYA^® (tildrakizumab-asmn)
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 and for the treatment of adults with active psoriatic arthritis, 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.

ILUMYA is the 1^st biologic to earn the National Psoriasis Foundation (NPF) Seal of Recognition. The NPF Seal recognizes products that meet the Foundation's established review criteria and reflects Sun's continued commitment to supporting people living with psoriatic disease.  

INDICATION

ILUMYA^® is indicated for the treatment of:

• moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• active psoriatic arthritis in adult patients.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a history of serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.

Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves.

Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with ILUMYA. 

ADVERSE REACTIONS
Most common adverse reactions associated with ILUMYA treatment are:

• Plaque Psoriasis (≥1%): upper respiratory infections, injection site reactions, and diarrhea. 
• Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19.

USE IN SPECIFIC POPULATIONS

Pregnancy
Advise patients that there is a pregnancy exposure registry that monitors outcomes in women exposed to ILUMYA during pregnancy.

Patients can enroll by calling MotherToBaby at 1-866-626-6847 or by visiting
https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn.

Please see Full Prescribing Information.

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050):
Sun Pharma is the world's leading specialty generics company with a presence in innovative medicines, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global Emerging Markets. Sun Pharma's high-growth global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on LinkedIn & X (Formerly Twitter).

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Contacts: Sun Pharma 

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SOURCE Sun Pharma