Sun Pharmaceutical Industries Limited announced via a regulatory filing under Regulation 30 of SEBI LODR that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ILUMYA® (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA).
The approval expands the use of ILUMYA beyond its initial indication for moderate-to-severe plaque psoriasis (PsO), for which it was approved in 2018. ILUMYA is an IL-23 inhibitor administered exclusively by a healthcare provider.
The approval is supported by two Phase 3 clinical studies: INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531). These were 52-week, global, multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of a 100 mg dose in adults with active psoriatic arthritis. The safety data from these studies was consistent with the drug's established profile, with no new safety signals identified.
The most common adverse reactions for the psoriatic arthritis indication are upper respiratory tract infections and COVID-19 (occurring in ≥3% of patients). For the plaque psoriasis indication, the most common adverse reactions (≥1%) are upper respiratory infections, injection site reactions, and diarrhea.
The announcement highlights that approximately 2.4 million Americans live with psoriatic arthritis. The company quotes Rick Ascroft, North America CEO of Sun Pharma, who stated the approval "represents another important innovative medicine milestone" and strengthens the company's portfolio in psoriatic disease. A clinical perspective was provided by Philip Mease, Director of Rheumatology Research at the Swedish Medical Center.
ILUMYA has also been approved for moderate-to-severe plaque psoriasis in other markets, including India, Australia, Canada, China, and Japan, and is marketed under the brand name ILUMETRI® in Europe by Almirall.