FDA Approves Sun Pharma's Ilumya for Active Psoriatic Arthritis

The Food and Drug Administration has approved Sun Pharmaceutical Industries' Ilumya (tildrakizumab-asmn) for adults with active psoriatic arthritis, the company said on October 30, extending the interleukin-23 (IL-23) inhibitor beyond the plaque psoriasis indication it has held since 2018.

In a release distributed by PR Newswire, Sun Pharma said the FDA approved its supplemental Biologics License Application (sBLA) for the new indication. The company described Ilumya as an "IL-23 inhibitor approved exclusively for healthcare provider-administered treatment."

The Phase 3 evidence

Sun Pharma said the approval is supported by two Phase 3 studies, INSPIRE-1 and INSPIRE-2, which evaluated the drug's efficacy and safety after two doses at 24 weeks in adults with active psoriatic arthritis. The trial results cited here are company-reported.

According to Healio, the release said both trials showed the drug was superior to placebo on the primary endpoint, ACR20 response at 24 weeks, a measure of at least 20% improvement in American College of Rheumatology criteria. Healio reported that the trials tested a 100 mg subcutaneous injection given at weeks 0 and 4, and every 12 weeks after that.

Pharmaceutical Executive reported that INSPIRE-1 enrolled patients who had previously taken a tumor necrosis factor (TNF) inhibitor and INSPIRE-2 enrolled patients who had not, with more than 800 participants in total. The publication noted that the announcement "cited no phase 3 efficacy figures" and did not address launch timing or pricing.

On safety, Sun Pharma said results were consistent with the drug's known profile and that no new safety signals were identified. The release lists upper respiratory tract infections and COVID-19 as the most common adverse reactions in the psoriatic arthritis studies, and its safety information calls for evaluation for tuberculosis infection before treatment starts.

Provider-administered positioning

"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," Rick Ascroft, Sun Pharma's North America CEO, said in the release.

Philip Mease of Swedish Medical Center and Providence St Joseph Health, who Healio identified as lead author of the INSPIRE trials, said in the release that clinicians "need a range of therapeutic options that allow us to individualize care based on each patient's symptoms and treatment goals."

The company estimates that as many as 2.4 million Americans live with psoriatic arthritis. Ilumya is also approved for plaque psoriasis in India, Australia, Canada, China and Japan, and is sold in Europe as Ilumetri by Almirall, according to the release.

What comes next

Pharmaceutical Executive reported that Sun Pharma said in 2025 that full Phase 3 findings would be presented at a future medical meeting and published. The INSPIRE trials are registered on ClinicalTrials.gov as NCT04314544 and NCT04314531, the release says. The trials were sponsored by Sun Pharma, according to Healio.