FDA approves tildrakizumab for psoriatic arthritis; half-life extended IL-23 antibody clears skin in 61% in phase 2b

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The Food and Drug Administration (FDA) approved Sun Pharma's tildrakizumab (Ilumya) for adults with active psoriatic arthritis, the company said Oct. 30. Oruka Therapeutics reported that its half-life extended IL-23p19 antibody ORKA-001 achieved complete skin clearance in 61% of high-dose patients in a phase 2b psoriasis trial.

  • FDA Oct 30, 2026
    The Food and Drug Administration (FDA) approved a supplemental biologics license application for tildrakizumab-asmn (Ilumya), an IL-23 inhibitor already approved for moderate to severe plaque psoriasis, for adults with active psoriatic arthritis, Sun Pharma said Oct. 30. In the phase 3 INSPIRE-1 trial, 61% of tildrakizumab patients achieved ACR20 at week 24 versus 35% on placebo; in INSPIRE-2, the rates were 64% and 33%, according to Dermatology Times. Philip Mease, director of rheumatology research at Swedish Medical Center and Providence St Joseph Health, said a provider-administered IL-23 inhibitor offers a new option.
  • Research Oct 26, 2026
    In the phase 2b EVERLAST-B trial of 187 patients with moderate to severe plaque psoriasis, 61% of those receiving 600 mg of ORKA-001, a half-life extended IL-23p19 antibody, achieved PASI 100 at week 16, the primary end point, versus 0% on placebo (P < .0001), according to company-reported interim results released Oct. 26. PASI 90 was reached by 86% in the high-dose group. Oruka said the drug may allow dosing once to twice a year and plans phase 3 trials in the first half of 2027.

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  2. FDA approves tildrakizumab (Ilumya) for adults with active psoriatic arthritis
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