NEW DELHI (dpa-AFX) - Sun Pharmaceutical Industries (SUNPHARMA) announced that the FDA has accepted for review the supplemental Biologics License Application for ILUMYA for the treatment of adults with active psoriatic arthritis. The FDA regulatory action date is expected by October 29, 2026. The sBLA is based on the results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies.
The company noted that if approved, this would mark a new indication for ILUMYA following its US FDA approval in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
At last close, Sun Pharma was trading at INR 1,776.00, down 1.42%.
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