Acceptance is based on pivotal Phase 3 data demonstrating rapid, durable and consistent skin clearance, including in high-impact sites, in a convenient once-daily pill
Results from nearly 3,000 patients support potential for next-generation TYK2 inhibitor to redefine oral treatment expectations in psoriasis
The Prescription Drug User Fee Act (PDUFA) target action date is in the first quarter of calendar year 2027
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.
Q&A:
What specific data supports the zasocitinib FDA acceptance?
The NDA filing is supported by the pivotal Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) studies, in which the co-primary and all 44 ranked secondary endpoints were met.1-2,6-7 The studies are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis.6-7 Co-primary and select secondary endpoints at week 16 included:1-2
|
Co-primary Endpoints and Select Secondary Endpoints at Week 16 |
LATITUDE PsO 3001 Results |
LATITUDE PsO 3002 Results |
|
static Physician Global Assessment (sPGA) 0/1 |
71% zasocitinib vs 11% placebo and 32% apremilast (p<0.001) |
69% zasocitinib vs 13% placebo and 30% apremilast (p<0.001) |
|
Psoriasis Area and Severity Index (PASI) 75 |
76% zasocitinib vs 12% placebo and 37% apremilast (p<0.001) |
71% zasocitinib vs 12% placebo and 33% apremilast (p<0.001) |
|
Select Secondary Endpoints at Week 16 |
|
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PASI 90 |
61% zasocitinib vs 5% placebo and 17% apremilast (p<0.001) |
52% zasocitinib vs 4% placebo and 16% apremilast (p<0.001) |
|
sPGA 0 |
40% zasocitinib vs 0.7% placebo and 8% apremilast (p<0.001) |
34% zasocitinib vs 1% placebo and 7% apremilast (p<0.001) |
|
PASI 100 |
33% zasocitinib vs 0.7% placebo and 3% apremilast (p<0.001) |
25% zasocitinib vs 1% placebo and 4% apremilast (p<0.001) |
|
Scalp-specific PGA (ssPGA) 0/1 |
77% zasocitinib vs 7% placebo and 42% apremilast (p<0.001) |
74% zasocitinib vs 13% placebo and 30% apremilast (p<0.001) |
|
Nail Psoriasis Severity Index (NAPSI), Least-squares mean change from baseline |
-7.1 zasocitinib vs 1.8 placebo (p<0.001) |
-8.6 zasocitinib vs -1.4 placebo (p<0.001) |
|
Palmoplantar (hands and/or feet response) PGA (hfPGA) 0/1* |
71% zasocitinib vs 22% placebo and 44% apremilast* |
69% zasocitinib vs 10% placebo and 43% apremilast* |
|
PASI 75 at Week 4 |
N/A |
17% zasocitinib vs 4% for placebo (p<0.001) |
|
Most Common Adverse Events (≥5%) |
Upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%), with no new safety signals identified** |
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*Not a multiplicity controlled secondary endpoint. Comparisons with apremilast are descriptive and should be interpreted accordingly. |
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**Sample size adjusted incidence proportion across the two studies. |
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