Sun Pharmaceutical Industries has secured a major regulatory milestone in the US, with the Food and Drug Administration (FDA) approving its drug ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA).

 

The approval of the supplemental Biologics License Application (sBLA) expands ILUMYA’s use beyond moderate-to-severe plaque psoriasis and strengthens Sun Pharma’s presence in the growing psoriatic disease treatment market.

 

The drug, an interleukin-23 (IL-23) inhibitor, is approved exclusively for administration by healthcare providers, offering a new treatment option for patients who cannot self-administer medication or may benefit from regular, supervised 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."

 

The approval targets a significant patient population. Approximately 2.4 million Americans live with psoriatic arthritis, a chronic inflammatory disease that can cause joint pain, swelling and stiffness and, if left unchecked, lead to permanent joint damage.

 

ILUMYA was first approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The latest regulatory clearance marks a significant expansion of the drug's therapeutic reach.

 

Highlighting the need for more treatment choices, 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, said individualised treatment remains critical in managing the disease.

 

"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 Mease.