Sun Pharma’s ILUMYA Approved by FDA for Psoriatic Arthritis Treatment

Sun Pharmaceutical Industries announced on Friday that the US Food and Drug Administration (FDA) has granted approval for its drug ILUMYA (tildrakizumab-asmn) to be used in treating adults with active psoriatic arthritis. This marks an expansion of the drug's approved use, which was previously limited to moderate-to-severe plaque psoriasis.

ILUMYA is a medication that targets interleukin-23 (IL-23), a protein involved in the inflammatory process. The drug works by blocking the p19 subunit of IL-23, thereby reducing the release of inflammatory cytokines and chemokines. It is administered via injection and must be given by healthcare professionals.

The drug first received FDA approval in 2018 for adults suffering from moderate-to-severe plaque psoriasis who require systemic therapy or phototherapy. The recent authorization covers its use in psoriatic arthritis, a chronic autoimmune condition characterized by joint pain, swelling, and stiffness. Psoriatic arthritis can affect tendon and ligament attachment sites and may result in permanent joint damage if untreated.

FDA’s approval was supported by positive results from two Phase 3 clinical trials, INSPIRE-1 and INSPIRE-2. These studies evaluated the drug's safety and efficacy in adult patients with active psoriatic arthritis, assessing outcomes at 24 weeks after two doses. The data confirmed ILUMYA’s benefits and safety profile, consistent with previous findings from its use in plaque psoriasis.

Rick Ascroft, the North America CEO of Sun Pharma, highlighted the significance of this milestone, stating that the approval represents an important achievement and builds upon the established clinical experience with ILUMYA in treating plaque psoriasis.

According to the company’s exchange filing, no new safety concerns emerged during the trials. However, ILUMYA may raise the risk of infections, and patients need to be screened for tuberculosis before beginning treatment. The most commonly reported adverse effects in the psoriatic arthritis patient group were upper respiratory tract infections and Covid-19.

Psoriatic arthritis affects approximately 2.4 million people in the United States. It is estimated that nearly one-third of individuals with psoriasis also develop this joint condition, and over 15 percent of psoriasis patients may have undiagnosed psoriatic arthritis. The condition’s chronic nature and potential for irreversible joint damage underscore the importance of effective treatment options.

Philip Mease, Director of Rheumatology Research at the Swedish Medical Center, commented on the approval, noting that having an IL-23 inhibitor administered by a healthcare provider offers patients additional support and closer engagement with their healthcare team.

ILUMYA is also approved for moderate-to-severe plaque psoriasis treatment in countries including India, Australia, Canada, China, and Japan. In Europe, the drug is marketed under the brand name ILUMETRI by Almirall.

Sun Pharma’s innovative medicines portfolio includes treatments across dermatology, ophthalmology, and onco-dermatology, contributing roughly 20 percent to the company’s overall sales. The FDA’s recent approval adds to the company’s expanding range of specialty therapies aimed at addressing complex medical conditions.