FDA & Government News

FDA Approves New Oral Option for Plaque Psoriasis

Phase 3 data showed high skin clearance rates and adverse event rates similar to placebo through week 16 with once-daily icotrokinra.

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The FDA has approved icotrokinra (ICOTYDE), an oral interleukin-23 receptor antagonist for treating moderate-to-severe plaque psoriasis in patients aged 12 and older, weighing at least 40 kg. This targeted therapy offers a new oral alternative to traditional injectable biologics and is beneficial for patients inadequately managed by topical treatments. The approval is based on phase 3 trials involving approximately 2,500 participants, demonstrating significant skin clearance and a favorable safety profile over 52 weeks. Plaque psoriasis severely impacts quality of life, affecting over 8 million individuals in the US.

Original Source(s)

FDA Approves New Oral Option for Plaque Psoriasis

  • by Kathryn Wighton

  • March 18, 2026

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