The FDA’s regulatory motion date for the applying is anticipated by October 29, 2026.
“For many people living with psoriatic disease, joint symptoms often add another layer of burden,” mentioned Rick Ascroft, CEO, Sun Pharma North America.
He added that the corporate seems ahead to working with the FDA through the overview course of and goals for ILUMYA to change into a differentiated first-choice superior systemic remedy for energetic psoriatic arthritis.
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The pharma firm mentioned that if authorised, the applying would add a brand new indication for ILUMYA. The remedy was authorised by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who’re candidates for systemic remedy or phototherapy. Supplemental approvals for scalp and nail plaque psoriasis have been granted in April 2024 and December 2025, respectively.
The pharma agency added that ILUMYA has obtained advertising authorisation from greater than 55 well being authorities worldwide since its unique approval, together with in India, Japan, the European Union, China, Australia and Canada.
The sBLA submission relies on outcomes from the INSPIRE-1 and INSPIRE-2 Phase 3 scientific research evaluating the efficacy and security of ILUMYA in adults with energetic psoriatic arthritis. Top-line outcomes from the research have been reported in July 2025, with additional particulars anticipated to be offered at a future congress, mentioned the corporate.
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The agency warned that ILUMYA might trigger critical unwanted effects, together with critical allergic reactions, and shouldn’t be taken by sufferers allergic to the drug. It might enhance the chance of infections and cut back the physique’s capacity to combat them.
Shares of Sun Pharmaceutical Industries Ltd ended at ₹1,776 on the National Stock Exchange of India on March 16, down ₹25.60 or 1.42% for the day.
