Japanese pharmaceutical company Takeda (TSE:4502) (NYSE:TAK) said on Monday that the US Food and Drug Administration (FDA) has accepted its new drug application for zasocitinib (TAK-279) under Priority Review for adults with moderate-to-severe plaque psoriasis.

The investigational oral TYK2 inhibitor is supported by Phase 3 data from nearly 3,000 patients, with the pivotal LATITUDE PsO 3001 and 3002 studies meeting all primary and ranked secondary endpoints.

About 70% of patients achieved clear or almost clear skin at week 16, with skin clearance observed from week four and increasing through weeks 24 and 52. The data also showed skin clearance across hard-to-treat and high-impact areas, including the scalp, nails, palms and soles.

Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with previous studies and no new safety signals identified.

The new drug application also includes supportive data from the open-label LATITUDE PsO 3003 study evaluating long-term safety, tolerability and efficacy.

The FDA's Prescription Drug User Fee Act target action date is in the first quarter of 2027.

Separately, the European Medicines Agency (EMA) has accepted Takeda's new marketing authorisation application for zasocitinib, initiating the review process for the treatment of moderate-to-severe plaque psoriasis. Takeda said it plans to submit additional applications to global regulatory authorities.