-Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its 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.^1-3

Addressing unmet needs in psoriasis treatment
“Despite progress in psoriasis care, there remains a need for highly effective oral therapies that also address the diverse and often challenging manifestations of psoriasis, including involvement of high-impact sites like the scalp,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Our Phase 3 data demonstrated rapid and durable skin clearance across various patient types and in high-impact and hard-to-treat areas. Based on the results across nearly 3,000 patients, zasocitinib has the potential to be a leading oral treatment option in psoriasis.”

Phase 3 clinical data supporting the zasocitinib NDA for moderate-to-severe plaque psoriasis
The NDA filing is supported by a comprehensive data package including the pivotal global Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) studies, in which all primary and ranked secondary endpoints were met.^1-2 The submission also included supportive data from LATITUDE PsO 3003 (NCT06550076), an open-label study to evaluate zasocitinib's long-term safety, tolerability and efficacy.⁴ Zasocitinib data demonstrated:^1-2

• 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 (sPGA 0/1) at week 16.
• 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.
• 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.⁵
• Zasocitinib was generally well tolerated, with a safety profile consistent with previous studies. No new safety signals were identified.

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.

The NDA filing has no significant impact on the full year consolidated financial forecast for the fiscal year ending March 31, 2027.