Biologics license application (BLA) stories

Oct 30, 2026

FDA approves tildrakizumab for psoriatic arthritis

The FDA cleared Sun Pharma's interleukin-23 inhibitor tildrakizumab (Ilumya) for the treatment of active psoriatic arthritis in adults, expanding the drug's approved indications.

Oct 30, 20263 sources

Top claims

▪Sun Pharma said that at 24 weeks in the INSPIRE-1 and INSPIRE-2 trials, significantly more patients receiving subcutaneous tildrakizumab 100 mg achieved ACR20 response compared to placebo after two doses
▪Approximately 2.4 million Americans live with psoriatic arthritis, a chronic immune-mediated disease causing joint pain, swelling, stiffness, and potential permanent joint damage
▪The FDA's approval of Ilumya for active psoriatic arthritis expands its use beyond moderate-to-severe plaque psoriasis, for which the drug was initially cleared in 2018

Subtopics

Autoimmune disease1 Autoimmune disease treatments1 Biologic therapies1 Clinical trials1 Drug Policy, Pricing & Approval1 FDA drug approval1

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