The regulatory action date for the humanised immunoglobulin G1, kappa (IgG1/k) monoclonal antibody sBLA review is anticipated by 29 October 2026.
If approved, this would expand the therapy’s indications beyond its existing FDA approval received in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Additional sBLAs for scalp and nail plaque psoriasis received approvals in April 2024 and December 2025, respectively.
Ilumya has also secured marketing authorisations from more than 55 health authorities globally since its original approval, including in Australia, Canada, China, the EU, India, and Japan.
The antibody has been used to treat nearly 140,000 patients worldwide since its approval.
The current sBLA is based on data from the INSPIRE-I and INSPIRE-II Phase III trials that are assessing the safety and efficacy of Ilumya in adults with active psoriatic arthritis.
Top-line outcomes from these studies were announced in July 2025.
Both INSPIRE-I and INSPIRE-II are multi-centre, global, double-blind, placebo-controlled, randomised 52-week trials assessing tildrakizumab 100mg in this population.
Sun Pharma North America CEO Rick Ascroft said: “For many people living with psoriatic disease, joint symptoms often add another layer of burden. As we continue to strengthen Sun Pharma’s innovative portfolio, we look forward to working with the FDA throughout the review process.
“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.”
In September 2024, Sun Pharma and Moebius Medical received fast track designation from the FDA for MM-II (Large Liposomes of DPPC [dipalmitoylphosphatidylcholine] and DMPC [1,2‐dimyristoyl‐sn‐glycero‐3‐phosphocholine]), a non-opioid treatment for osteoarthritis knee pain.