Sun Pharmaceutical Industries Limited (Sun Pharma) has received approval from the US Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for ILUMYA® (tildrakizumab-asmn) to treat adults with active psoriatic arthritis (PsA). The approval expands the use of ILUMYA, an interleukin-23 (IL-23) inhibitor, which was approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriatic arthritis is a chronic inflammatory disease that can cause joint pain, swelling and stiffness. If left uncontrolled, it may lead to permanent joint damage. Approximately 2.4 million people in the United States are affected by the condition.
Rick Ascroft, Chief Executive Officer of Sun Pharma North America, said the approval adds another indication to the company’s innovative medicines portfolio and builds on the clinical experience of ILUMYA in plaque psoriasis. He said the treatment is administered by healthcare professionals and offers an option for patients who cannot self-administer medicines or prefer regular in-clinic care.
The FDA approval is supported by the Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA in adults with active psoriatic arthritis. The studies assessed outcomes at 24 weeks following two doses of treatment. According to the company, the safety findings were consistent with the established safety profile of ILUMYA, and no new safety signals were identified.
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, said treatment choices for psoriatic arthritis need to address individual patient symptoms and goals. He said a healthcare-provider-administered IL-23 inhibitor would add another option for suitable patients.
Sun Pharma said ILUMYA may increase the risk of infection and patients should be evaluated for tuberculosis before treatment begins. Common adverse reactions reported in plaque psoriasis include upper respiratory infections, injection-site reactions and diarrhoea. For psoriatic arthritis, commonly reported reactions include upper respiratory tract infections and COVID-19.
Sun Pharma is a global pharmaceutical company with businesses in specialty medicines, generics and consumer healthcare. It is India’s largest pharmaceutical company and operates in more than 100 countries. Its innovative medicines portfolio includes products in dermatology, ophthalmology and onco-dermatology, while its manufacturing facilities are spread across six continents.
