News ArticleSun Pharma’s ILUMYA® Gains FDA Approval for Treating Adults with Active Psoriatic Arthritis in U.S.
Approval expands ILUMYA’s indications beyond plaque psoriasis supported by Phase 3 clinical trials INSPIRE-1 and INSPIRE-2
Sun Pharmaceutical Industries announced the FDA approval of ILUMYA (tildrakizumab-asmn) for treating adults with active psoriatic arthritis, expanding its use from moderate-to-severe plaque psoriasis. The approval is supported by Phase 3 INSPIRE-1 and INSPIRE-2 studies demonstrating efficacy and safety over 24 weeks.
Sun Pharmaceutical Industries Limited
New Ventures
Sun Pharmaceutical Industries Limited announced that the U.S. FDA approved ILUMYA® (tildrakizumab-asmn) for adult patients with active psoriatic arthritis, extending its previous approval for moderate-to-severe plaque psoriasis.
ILUMYA, an interleukin-23 (IL-23) inhibitor administered exclusively by healthcare providers, now provides a treatment option for adults suffering psoriatic arthritis who may benefit from in-office administration or are unable to self-administer therapy.
The approval was granted following positive outcomes from Phase 3 INSPIRE-1 and INSPIRE-2 randomized, double-blind, placebo-controlled clinical trials assessing efficacy and safety after two doses at 24 weeks in adult patients with active psoriatic arthritis.
Safety data from these studies aligned with ILUMYA’s established safety profile, noting risks such as increased infections, including upper respiratory infections and COVID-19, and the necessity to evaluate patients for tuberculosis before starting therapy.
Psoriatic arthritis affects about 2.4 million Americans and can cause joint pain, swelling, and stiffness, with potential for permanent joint damage, often occurring in people with psoriasis.
ILUMYA is also approved for moderate-to-severe plaque psoriasis in multiple countries and carries the National Psoriasis Foundation Seal of Recognition for meeting established review criteria.
Highlights
- FDA approved ILUMYA (tildrakizumab-asmn) for treating active psoriatic arthritis in adults in the United States.
- Expanded indication beyond moderate-to-severe plaque psoriasis, previously approved in 2018.
- Approval supported by Phase 3 INSPIRE-1 and INSPIRE-2 studies demonstrating efficacy and safety after two doses at 24 weeks.
- ILUMYA is administered exclusively by healthcare providers, benefitting patients unable to self-administer.
- Approximately 2.4 million Americans live with psoriatic arthritis, characterized by joint pain and possible permanent damage.
- Safety profile consistent, with common adverse reactions including upper respiratory infections and injection site reactions.
Key Data Snapshot
What happened
- Sun Pharmaceutical Industries received FDA approval for ILUMYA® (tildrakizumab-asmn) to treat adults with active psoriatic arthritis in the U.S.
- The approval expands ILUMYA’s indications beyond its 2018 approval for moderate-to-severe plaque psoriasis.
- ILUMYA is an IL-23 inhibitor administered exclusively by healthcare providers, offering treatment options for patients unable to self-inject.
Key details
- Phase 3 clinical trials INSPIRE-1 and INSPIRE-2 demonstrated ILUMYA’s efficacy and safety after two doses at 24 weeks for active psoriatic arthritis patients.
- Safety profile consistent with prior clinical data; most common adverse reactions include upper respiratory infections and injection site reactions.
- Patients must be evaluated for tuberculosis before initiating ILUMYA, as treatment may increase infection risks.
Background and context
- Approximately 2.4 million Americans live with psoriatic arthritis, which can cause joint pain, swelling, stiffness, and potential permanent joint damage.
- One in three people with psoriasis may also have psoriatic arthritis; the disease can occur regardless of psoriasis severity.
- ILUMYA previously held approvals for moderate-to-severe plaque psoriasis in multiple countries and holds the National Psoriasis Foundation Seal of Recognition.
Regulatory and governance context
- ILUMYA is contraindicated in patients with serious hypersensitivity to the drug or excipients.
- The approval is based on a supplemental Biologics License Application (sBLA) accepted by the FDA.
- Sun Pharma disclosed safety warnings including hypersensitivity, infection risks, tuberculosis evaluation, and immunization considerations before treatment.
Highlights
- FDA approved ILUMYA (tildrakizumab-asmn) for treating active psoriatic arthritis in adults in the United States.
- Expanded indication beyond moderate-to-severe plaque psoriasis, previously approved in 2018.
- Approval supported by Phase 3 INSPIRE-1 and INSPIRE-2 studies demonstrating efficacy and safety after two doses at 24 weeks.
- ILUMYA is administered exclusively by healthcare providers, benefitting patients unable to self-administer.
- Approximately 2.4 million Americans live with psoriatic arthritis, characterized by joint pain and possible permanent damage.
- Safety profile consistent, with common adverse reactions including upper respiratory infections and injection site reactions.
Disclosures
- SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
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