FDA Accepts Takeda's Zasocitinib NDA Under Priority Review for Plaque Psoriasis

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โดย Business Wire·USJP·Read original
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Takeda announced that the U.S. Food and Drug Administration has accepted its New Drug Application under Priority Review for zasocitinib, also known as TAK-279, for the treatment of adults with moderate-to-severe plaque psoriasis, with a Prescription Drug User Fee Act target action date in the first quarter of calendar year 2027. The filing is supported by the pivotal global Phase 3 LATITUDE PsO 3001 and 3002 studies, in which all primary and ranked secondary endpoints were met, plus supportive data from the open-label LATITUDE PsO 3003 study. Across the program, roughly 70% of patients achieved clear or almost clear skin at week 16, with clearance observed as early as week 4 and increasing through week 24 and week 52, including at hard-to-treat sites such as the scalp, nails, palms and soles. Andy Plump, president of R&D at Takeda, said the results across nearly 3,000 patients suggest zasocitinib has the potential to be a leading oral treatment option in psoriasis. The European Medicines Agency has also accepted Takeda's marketing authorization application for zasocitinib, and Takeda said the NDA filing has no significant impact on its full year consolidated financial forecast for the fiscal year ending March 31, 2027.

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FDA accepted Takeda's NDA for zasocitinib under Priority Review for plaque psoriasis, advancing the regulatory path toward approval.

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