Sun Pharmaceutical industries’ (Sun Pharma) supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab) to treat adults with active psoriatic arthritis (PsA) has been accepted for review by the US FDA. 

The FDA regulatory action date for this sBLA is expected by 29 October 2026. If approved, this would mark a new indication for ILUMYA following its US FDA approval in 2018 to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Scalp and nail plaque psoriasis sBLAs were approved in April 2024 and December 2025, respectively. 

Since the initial FDA approval, ILUMYA has received marketing authorisation from over 55 health authorities globally, including the EU, Canada, Australia, India, Japan and China. 

Having supported nearly 140,000 patients worldwide with durable skin clearance, ILUMYA is a humanised IgG1/k monoclonal antibody that inhibits the release of pro-inflammatory cytokines and chemokines. 

With five years of clinical follow-up, ILUMYA has a well-characterised safety profile. Real-world experience also shows a strong adherence and persistence, which helps patients to keep using the treatment long term. 

Results from the phase 3 clinical studies, INSPIRE-1 and INSPIRE-2, which evaluated the efficacy and safety of the treatment in adult patients with active PsA form the basis of the sBLA. 

The most common side effects of ILUMYA are upper respiratory tract infection, injection site reactions and diarrhoea. 

Rick Ascroft, CEO, Sun Pharma North America, said: “For many people living with psoriatic disease, joint symptoms often add another layer of burden. 

“As the only HCP-administered IL-23 biologic, our ambition is that ILUMYA becomes a differentiated first-choice advanced systemic treatment for active psoriatic arthritis.”

Causing swelling, pain and stiffness, PsA affects up to 2.4 million people in the US and roughly one in three people living with psoriasis.