- US FDA approves ILUMYA for adults with active psoriatic arthritis
- Approval expands the drug’s use beyond moderate-to-severe plaque psoriasis
- IL-23 inhibitor to be administered exclusively by healthcare providers
- Phase 3 INSPIRE-1 and INSPIRE-2 studies support the regulatory approval
- Sun Pharma highlights an additional treatment option for patients requiring supervised care
NE HEALTH BUREAU
MUMBAI, PRINCETON, NJ, OCT 30
Sun Pharmaceutical Industries Limited on Friday announced that 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 (PsA), expanding the medicine’s use into another major area of psoriatic disease.
The approval marks an important development for Sun Pharma’s US portfolio, extending ILUMYA beyond its existing indication for adults with moderate-to-severe plaque psoriasis. The IL-23 inhibitor is approved exclusively for administration by healthcare providers, offering an additional treatment option for eligible patients who may be unable to self-administer medication or prefer regular in-office care.
“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,” said Rick Ascroft, North America CEO, Sun Pharma.
“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,” he added.
Approximately 2.4 million Americans live with psoriatic arthritis, a chronic inflammatory condition that can cause joint pain, swelling and stiffness, potentially leading to permanent joint damage.
The latest approval expands the use of ILUMYA, which received FDA approval in 2018 for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
“Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualize 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,” said Philip Mease, Director of Rheumatology Research at the Swedish Medical Center and Providence St Joseph Health, and Clinical Professor at the University of Washington School of Medicine, Seattle, Washington.
The approval is supported by the Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA after two doses at 24 weeks in adult patients with active psoriatic arthritis.
Safety findings from the studies were consistent with ILUMYA’s established safety profile, with no new safety signals identified in either trial.
However, ILUMYA may increase the risk of infection. Patients should be evaluated for tuberculosis (TB) infection before initiating treatment. The most common adverse reactions reported were upper respiratory infections, injection-site reactions and diarrhoea in plaque psoriasis patients (at least 1%), and upper respiratory tract infections and COVID-19 in psoriatic arthritis patients (at least 3%).