NSEPress Release1d ago · 30 Oct 2026, 08:05 am
Press Release
Sun Pharmaceutical Industries Limited · SUNPHARMA
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Sun Pharmaceutical Industries Limited has announced that the U.S. FDA has approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis, expanding the use of ILUMYA beyond moderate-to-severe plaque psoriasis.
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Sun Pharmaceutical Industries Limited has informed the Exchange regarding a press release dated October 30, 2026, titled "ILUMYA® (tildrakizumab-asmn) approved in the U.S. for the Treatment of Adults with Active Psoriatic Arthritis".
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Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai – 400 063, Maharashtra, INDIA.
Tel.: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Website: www.sunpharma.com
Email: secretarial@sunpharma.com
CIN: L24230GJ1993PLC019050
30 October 2026
National Stock Exchange of India Limited BSE Limited
Scrip Symbol: SUNPHARMA Scrip Code: 524715
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations,
2015 – Press Release
Enclosed herewith is a copy of the press release titled “ILUMYA® (tildrakizumab-asmn) approved in the U.S.
for the Treatment of Adults with Active Psoriatic Arthritis” which shall be released after this intimation.
For Sun Pharmaceutical Industries Limited
(Anoop Deshpande)
Company Secretary and Compliance Officer
ICSI Membership No.: A23983
Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA.
Reaching People. Touching Lives.
Sun Pharmaceutical Industries, Inc.
Sun House, Plot No. 201 B/1, Western
Express Highway Goregaon (E)
Mumbai – 400 063, Maharashtra, INDIA
Tel.: (91-22) 4324 4324
Fax.: (91-22) 4324 4343
Website : www.sunpharma.com
Email : secretarial@sunpharma.com
CIN : L24230GL1883PLC019050
FOR IMMEDIATE RELEASE
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, NJ, (October 30, 2026) – 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 1st 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.
Reaching People. Touching Lives
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 tre
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