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The US FDA Grants Priority Review to Takeda’s Zasocitinib in Plaque Psoriasis

Shots:

  • The US FDA has accepted the NDA & granted priority review to zasocitinib (TAK-279) for the treatment of adults with mod. to sev. plaque psoriasis (PsO), with the PDUFA target action date in Q1’27. MAA is under EMA’s review, with further global filings planned
  • NDA was supported by extensive data incl. global P-III (Latitude PsO 3001 & PsO 3002) studies, which met their 1 & 2EPs, plus LATITUDE PsO 3003, an open-label study, to assess zasocitinib’s long-term safety, tolerability & efficacy  
  • TAK-279 showed significant skin clearance & symptom relief, with ~70% pts achieving clear/almost clear skin (sPGA 0/1) by Wk. 16, rapid & durable clearance from Wk. 4 through Wk. 52, & strong efficacy at across hard-to-treat & high-impact sites incl. the scalp, nails, palms & soles

Ref: Businesswire  |  Image: Takeda  |  Press Release

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