Sun Pharma Expands ILUMYA's Label with USFDA Approval for Psoriatic Arthritis
New Delhi: Indian drugmaker Sun Pharmaceutical Industries Limited (Sun Pharma) has received approval from the US Food and Drug Administration (USFDA) for the supplemental Biologics License Application (sBLA) of ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA).
The approval expands the indications for ILUMYA, an interleukin-23 (IL-23) inhibitor, which was earlier approved by the USFDA in 2018 for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
"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.
He added that ILUMYA, administered exclusively by a healthcare provider, offers an option for adults with active psoriatic arthritis who are unable to self-administer treatment or may benefit from regular in-office care.
Psoriatic arthritis is a chronic immune-related disease that causes joint pain, swelling and stiffness and may lead to permanent joint damage. Approximately 2.4 million Americans live with the condition, according to the company.
The approval is supported by the Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA in adults with active psoriatic arthritis. The studies assessed treatment outcomes after two doses at 24 weeks.
Safety data from the studies were consistent with ILUMYA's established safety profile, with no new safety signals identified.
Commenting on the approval, Philip Mease, Director of Rheumatology Research at Swedish Medical Center and Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine, said that psoriatic arthritis is a complex and chronic disease requiring a range of treatment options tailored to patients' symptoms and treatment goals.
He added that the availability of an IL-23 inhibitor administered by a healthcare provider provides another option to support appropriate patients and their engagement with healthcare teams.
ILUMYA may increase the risk of infections, and patients should be evaluated for tuberculosis (TB) infection before initiating treatment. The most common adverse reactions reported in plaque psoriasis patients (1% or more) include upper respiratory infections, injection-site reactions and diarrhoea. In psoriatic arthritis patients (3% or more), the most common adverse reactions include upper respiratory tract infections and COVID-19.
ILUMYA is a humanised IgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of IL-23 and inhibit its interaction with the IL-23 receptor, thereby reducing the release of pro-inflammatory cytokines and chemokines.
In the US, the drug is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as adults with active psoriatic arthritis.
Sun Pharma also markets ILUMYA for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan. In Europe, it is marketed under the brand name ILUMETRI by Almirall.
