The US 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.

Rick Ascroft, CEO, North America, Sun Pharma, said, "FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis. As an IL-23 inhibitor administered exclusively by a healthcare provider, ILUMYA is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care."

Approximately 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 FDA in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Philip Mease, Director of Rheumatology Research, Swedish Medical Center and Providence St Joseph Health and Clinical Professor, University of Washington School of Medicine, Seattle, WA, said, "Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualise care based on each patient’s symptoms and treatment goals. Adding an IL-23 inhibitor option that is administered by a healthcare provider gives us a new way to offer appropriate patients additional support and engagement with their healthcare team.”

The approval is supported by phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA after only 2 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. Most common Adverse Reactions (ARs) are: plaque psoriasis (≥1 percent): upper respiratory infections, injection site reactions, and diarrhea. psoriatic arthritis (≥3 percent): upper respiratory tract infections and COVID-19.