US FDA Grants Priority Review to Zasocitinib for Moderate to Severe PsO
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Takeda's zasocitinib receives FDA Priority Review for the treatment of adults with moderate-to-severe plaque psoriasis, following successful Phase 3 trials.
The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis.
Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable and consistent skin clearance in Phase 3 plaque psoriasis studies.
The NDA filing is supported by the pivotal global Phase 3 LATITUDE PsO 3001 and 3002 (NCT06108544) studies, in which all primary and ranked secondary endpoints were met. The submission also included supportive data from LATITUDE PsO 3003, an open-label study to evaluate zasocitinib’s long-term safety, tolerability and efficacy. Zasocitinib data demonstrated statistically significant and clinically meaningful improvements across multiple measures of skin clearance and symptom relief, with about 70% of patients achieving clear or almost clear skin (Static Physician Global Assessment [sPGA]: sPGA 0/1) at Week 16. In addition, there was rapid and durable skin clearance for the majority of patients, with clearance observed as early as Week 4 and increasing through Week 24 and further through Week 52. Patients taking Zasocitinib also showed high levels of skin clearance across hard-to-treat and high-impact sites, including the scalp, nails, palms and soles, which can result in reduced quality of life for patients. Zasocitinib was generally well tolerated, with a safety profile consistent with previous studies. No new safety signals were identified.
The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis.
Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable and consistent skin clearance in Phase 3 plaque psoriasis studies.
Next Steps for Zasocitinib
The European Medicines Agency (EMA) also accepted Takeda’s new marketing authorization application (MAA) for zasocitinib, initiating the review process for the treatment of moderate-to-severe plaque psoriasis. Takeda plans to submit additional applications for plaque psoriasis with global regulatory authorities to bring zasocitinib to people living with psoriasis worldwide.
