StoryRegulatory
FDA accepts Zasocitinib (TAK-279) NDA under Priority Review for moderate-to-severe plaque psoriasis; PDUFA decision Q1 2027
The FDA accepted Takeda's application for Zasocitinib for plaque psoriasis under expedited Priority Review. Phase 3 trials demonstrated ~70% of patients cleared their skin at week 16, outperforming existing treatments. The regulatory decision target is Q1 2027; the drug is also in testing for psoriatic arthritis and inflammatory bowel disease.
- FDA Priority Review grants faster decision; PDUFA target Q1 2027
- Phase 3: ~70% achieved clear or nearly clear skin at week 16 (sPGA 0/1)
- Advancing Phase 2/3 trial for psoriatic arthritis and Phase 3 for IBD