Cambridge, Mass. — Takeda said the U.S. Food and Drug Administration has accepted its New Drug Application for zasocitinib, or TAK-279, under Priority Review for the treatment of adults with moderate-to-severe plaque psoriasis.
Zasocitinib is an investigational oral tyrosine kinase 2, or TYK2, inhibitor. The FDA has set a Prescription Drug User Fee Act target action date in the first quarter of 2027.
The application is supported by data from the global Phase 3 LATITUDE PsO 3001 and 3002 studies, along with supportive data from the LATITUDE PsO 3003 long-term study. Takeda said the pivotal trials met all primary and ranked secondary endpoints.
About 70% of patients treated with zasocitinib achieved clear or almost clear skin at week 16, according to the company. Takeda also reported skin clearance beginning as early as week 4 and continuing through weeks 24 and 52, including improvements in hard-to-treat areas such as the scalp, nails, palms and soles.
“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.”
Takeda said zasocitinib was generally well tolerated in the Phase 3 studies, with no new safety signals identified.
The European Medicines Agency has also accepted Takeda’s marketing authorization application for zasocitinib for moderate-to-severe plaque psoriasis. The company plans additional regulatory submissions in other markets.
Zasocitinib is designed to selectively inhibit TYK2, an enzyme involved in immune pathways linked to psoriasis and other inflammatory diseases. Takeda is also evaluating the drug in studies of psoriatic arthritis, Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.
