Sun Pharma Awaits FDA Decision on ILUMYA for Psoriatic Arthritis by 29 October
Key Facts
The US Food and Drug Administration accepted Sun Pharma’s supplemental application to license ILUMYA for adults with active psoriatic arthritis, the company announced on 16 March 2026. Acceptance means the application has entered regulatory review; it does not establish that a new approval has been issued for the proposed use. The company said the expected regulatory action date is 29 October 2026. Until then, use of ILUMYA for psoriatic arthritis remains proposed, not an approved indication on the current official label. The review record therefore corrects the claim in the previous version that the FDA had already approved the treatment.
The step concerns a supplemental application, or the addition of a proposed indication to the drug’s existing authorization. Sun Pharma said the FDA accepted its sBLA for review and that the proposed use targets adults with active psoriatic arthritis. If approved, the application would expand the drug’s indications; the company, however, has made that expansion conditional on approval. The official label published by the FDA specifies ILUMYA for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It does not list psoriatic arthritis as an indication.
The company is supporting its application with results from the Phase 3 INSPIRE-1 and INSPIRE-2 studies. In an announcement issued in July 2025, it said both studies met their primary endpoint and that a greater proportion of patients who received tildrakizumab achieved an ACR20 response at week 24 than those who received placebo, with statistical significance at p < 0.05. It also reported greater improvement in psoriatic arthritis signs and symptoms at week 24 with treatment than with placebo. These results support the clinical application filed by the company, but do not replace the FDA’s decision on the proposed indication.
Each of the two studies ran for 52 weeks and was global, multicenter, randomized and double-blind, comparing treatment at one dose with placebo. Sun Pharma said more than 800 adults took part across clinical sites in the United States, Europe and Asia. The follow-up period and participant count provide context for reading the week 24 results within a longer research program, while the company described both studies as Phase 3. The materials available here did not provide additional response-rate or magnitude-of-improvement figures, so the quantitative detail on the results is limited to the company’s reported comparison at week 24.
On safety, the company said the data from both studies were consistent with ILUMYA’s known safety profile and that no new safety signals were observed. This is Sun Pharma’s summary of the INSPIRE-1 and INSPIRE-2 data, alongside the efficacy results it said met the primary endpoint. The decision on whether to accept the proposed use rests with the FDA, with the company expecting regulatory action by 29 October 2026. The announcement of the date did not include a final review outcome.
The application concerns a drug that was previously approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to Sun Pharma. The official label confirms this existing indication and states that the treatment is for plaque psoriasis in adults eligible for systemic therapy or phototherapy. Psoriatic arthritis is the new use the company is seeking to add through the supplemental application. Sun Pharma estimated that about one in three people with psoriasis also have the disease, illustrating the group targeted by the proposed indication.