FDA approves ILUMYA for adults with psoriatic arthritis
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The FDA approved ILUMYA for adults with active psoriatic arthritis, based on Phase III INSPIRE-1 and INSPIRE-2 trials assessing efficacy and safety.
In the United States, the Food and Drug Administration (FDA) approved a supplemental biologics license application for ILUMYA (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. Sun Pharmaceutical Industries Limited announced the decision, and News-Medical published the announcement.
ILUMYA is an interleukin-23 inhibitor administered by a healthcare professional. According to Sun Pharma, the drug may be a treatment option for patients who cannot self-administer medication or may benefit from regular medical care during clinic visits.
In 2018, the FDA approved ILUMYA for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriatic arthritis can cause joint pain, swelling and stiffness and lead to irreversible joint damage.
Clinical trial data
The approval is based on the results of the global multicenter Phase III INSPIRE-1 and INSPIRE-2 trials. These were randomized, double-blind, placebo-controlled 52-week studies that assessed the efficacy and safety of 100 mg tildrakizumab in adults with active psoriatic arthritis. The drug's efficacy and safety were also assessed 24 weeks after two doses.
The company said the safety data were consistent with ILUMYA's known profile, and no new safety signals were identified in the trials. At the same time, the drug may increase the risk of infections, so patients should be screened for tuberculosis before starting therapy. The most common adverse reactions among patients with psoriatic arthritis, occurring in at least 3% of cases, were upper respiratory tract infections and COVID-19.
