Indian pharmaceutical company Sun Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) to use its medicine Ilumya for treating adults with active psoriatic arthritis.
The approval expands the medicine’s existing use beyond plaque psoriasis and introduces another treatment option for adults affected by this chronic inflammatory condition.
Ilumya contains tildrakizumab, an IL-23 inhibitor that works by targeting a specific part of the immune system involved in inflammation.
What Is Psoriatic Arthritis?
Psoriatic arthritis is a chronic inflammatory disease that affects people with psoriasis. It can cause joint pain, swelling, stiffness and inflammation, potentially affecting everyday activities.
The condition requires appropriate medical management to control symptoms and reduce the risk of long-term joint damage.
Approval Supported by Two Phase 3 Clinical Trials
The FDA decision was supported by two Phase 3 clinical studies, INSPIRE-1 and INSPIRE-2. Together, the trials involved more than 800 participants with active psoriatic arthritis.
The studies evaluated Ilumya against a placebo over a 52-week period. The treatment met the ACR20 response endpoint at Week 24, indicating improvement in arthritis symptoms according to the clinical assessment criteria.
Treatment to Be Administered by Healthcare Professionals
One important feature of Ilumya is that it is administered by healthcare professionals rather than being self-administered by patients.
The medicine was initially approved in 2018 for adults with moderate-to-severe plaque psoriasis. The latest FDA decision adds active psoriatic arthritis to its approved uses in the United States.
The development marks an expansion of Sun Pharma’s presence in the treatment of immune-related inflammatory conditions.
