The FDA has accepted Takeda’s new drug application for zasocitinib, an investigational oral treatment for adults with moderate-to-severe plaque psoriasis and granted the submission Priority Review.
The FDA has set a target action date in the first quarter of 2027. FDA acceptance of the application does not constitute approval, and zasocitinib is not currently approved for use by any regulatory authority.
The application is supported by Takeda’s Phase III LATITUDE PsO 3001 and PsO 3002 trials, which compared once-daily zasocitinib with placebo and apremilast in adults with moderate-to-severe plaque psoriasis.
The PsO 3001 trial enrolled 693 participants, while PsO 3002 enrolled 1,108. At Week 16, 71% of patients treated with zasocitinib in PsO 3001 and 69% in PsO 3002 achieved clear or almost clear skin under the static Physician Global Assessment measure. The reported rates were 11% and 13%, respectively, for placebo and 32% and 30% for apremilast.
For the Psoriasis Area and Severity Index 75 endpoint, 76% of participants receiving zasocitinib in PsO 3001 and 71% in PsO 3002 achieved at least a 75% improvement from baseline. The corresponding placebo rates were 12% in both studies, while apremilast rates were 37% and 33%.
Takeda said both studies met their co-primary endpoints and all 44 ranked secondary endpoints. Its submission also included long-term safety and efficacy information from the open-label LATITUDE PsO 3003 study.
The most common adverse events across the two pivotal trials, reported in at least 5% of patients, were upper respiratory tract infection, acne and nasopharyngitis. Takeda said no new safety signals were identified.
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