FDA grants Priority Review to Takeda’s zasocitinib for moderate to severe plaque psoriasis

The U.S. Food and Drug Administration has accepted Takeda’s New Drug Application for zasocitinib, also known as TAK 279, under Priority Review for the treatment of adults with moderate to severe plaque psoriasis.

A regulatory decision is expected during the first quarter of 2027 under the Prescription Drug User Fee Act timeline.

Zasocitinib is an investigational oral tyrosine kinase 2 inhibitor designed to selectively and potently target TYK2. Takeda is developing the treatment as a once daily oral option for people with plaque psoriasis.

The application is supported by Phase III data involving almost 3,000 patients, including results from the pivotal LATITUDE PsO 3001 and LATITUDE PsO 3002 studies.

Both trials achieved all of their primary and ranked secondary endpoints, with zasocitinib producing statistically significant and clinically meaningful improvements across several measures of skin clearance and symptom control.

At week 16, around 70% of patients achieved clear or almost clear skin according to the static Physician’s Global Assessment measure.

Improvements were seen relatively early in treatment, with skin clearance observed from week 4. Responses continued to increase through week 24 and were maintained or improved further through week 52.

Takeda also reported positive results in areas that can be particularly difficult to treat and have a significant impact on quality of life, including the scalp, nails, palms and soles.

Andy Plump, MD, PhD, President of Research and Development at Takeda, said that despite advances in psoriasis treatment, there remains a need for effective oral options that can address a wide range of disease manifestations.

He said the Phase III programme demonstrated rapid and sustained skin clearance across different patient groups, including those with psoriasis affecting difficult to treat areas, and added that zasocitinib has the potential to become a leading oral treatment option.

The regulatory submission also includes supportive findings from LATITUDE PsO 3003, an open label study evaluating the long term safety, tolerability and efficacy of zasocitinib.

Across the clinical programme, the treatment was generally well tolerated and its safety profile remained consistent with previous studies. No new safety signals were identified.

Takeda is also progressing regulatory review of zasocitinib outside the U.S. The European Medicines Agency has accepted the company’s marketing authorisation application for the treatment of moderate to severe plaque psoriasis.

Additional submissions are planned with regulatory authorities in other markets as Takeda seeks to expand access to the investigational therapy globally.

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Related Topics and Keywords

clinical trials, dermatology, FDA, pharma news, Plaque Psoriasis, psoriasis, skin health, Takeda, zasocitinib