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Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots:

  • The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO
  • NDA was backed by P-III (ICONIC-TOTALICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear skin at Wk. 16 in pediatric pts
  • ICONIC-TOTAL depicted icotrokinra’s potential in difficult-to-treat scalp & genital PsO, while ICONIC-ADVANCE 1 & 2 (vs PBO & Sotyktu) met its co-1EPs (IGA 0/1 & PASI 90) & key 2EPs at Wk. 16 & 24. Long term data incl. 52wk. data from ICONIC-LEAD & ICONIC-TOTAL, plus results from withdrawal analysis to be presented in future

Ref: Johnson & Johnson Image: Johnson & Johnson | Press Release

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