Sun Pharmaceutical Industries has received the U.S. Food and Drug Administration’s (USFDA) approval for its the supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA). Around 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 USFDA in 2018 for the treatment of adults with moderateto-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
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.
Sun Pharmaceutical Industries is engaged in the business of manufacturing, developing and marketing a wide range of branded and generic formulation and Active Pharmaceutical ingredients (APIs).
