Sun Pharma has received approval from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for 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 that received FDA approval in 2018 for treating adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
The expanded approval is supported by the Phase 3 INSPIRE-1 and INSPIRE-2 clinical trials, which evaluated the efficacy and safety of ILUMYA after only two doses at 24 weeks in adult patients with active psoriatic arthritis.
“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.
Psoriatic arthritis
Psoriatic arthritis (PsA) is a chronic immune-mediated disease that causes swelling, pain and stiffness in the joints and entheses (where tendons and ligaments connect to bones). The condition can lead to permanent joint damage.
Psoriatic arthritis can develop at any age and may occur regardless of the severity of psoriasis, which can range from mild to severe. Approximately one in three people living with psoriasis also develop psoriatic arthritis, with psoriasis typically appearing first.
Sun Pharma cited that an estimated 2.4 million people in the US live with psoriatic arthritis. However, more than 15% of people with psoriasis may have undiagnosed psoriatic arthritis.
“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,” said 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, Seattle.
“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,” he added.
About ILUMYA
ILUMYA (tildrakizumab-asmn) is a humanised IgG1/kappa monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), preventing its interaction with the IL-23 receptor. This inhibits the release of pro-inflammatory cytokines and chemokines.
In the US, ILUMYA is now approved 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.
ILUMYA has also been approved 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.
ILUMYA is the first biologic to receive the National Psoriasis Foundation (NPF) Seal of Recognition. The seal recognises products that meet the Foundation’s established review criteria.
