Takeda Pharmaceutical said on September 11 (US Eastern Time) that the US Food and Drug Administration accepted its new drug application for zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis and put it on priority review. The FDA's target decision date under the Prescription Drug User Fee Act falls in the first quarter of calendar 2027, meaning sometime between January and March, not a fixed day.
Acceptance for review is a procedural milestone, not a verdict on the drug.
The filing rests on two placebo- and active-comparator-controlled phase 3 trials run across 21 countries: LATITUDE PsO 3001, with 693 patients, and LATITUDE PsO 3002, with 1,108 patients, plus supplementary long-term safety data from the open-label LATITUDE PsO 3003 study, which enrolled about 2,100 patients. Both pivotal trials hit their two co-primary endpoints and all 44 ranked secondary endpoints. Company officials describe the combined program, covering close to 3,000 patients, as showing about 70% of patients reaching clear or almost-clear skin at 16 weeks.
Broken out by trial, the comparison against both placebo and apremilast, an existing oral psoriasis drug, looked like this:
| Endpoint | PsO 3001 (n=693) | PsO 3002 (n=1,108) |
|---|---|---|
| Clear or almost-clear skin (sPGA 0/1) | 71% zasocitinib vs 11% placebo vs 32% apremilast (p<0.001) | 69% vs 13% placebo vs 30% apremilast (p<0.001) |
| 75% skin-area improvement (PASI 75) | 76% vs 12% placebo vs 37% apremilast (p<0.001) | 71% vs 12% placebo vs 33% apremilast (p<0.001) |
Zasocitinib also improved psoriasis at the scalp, nails, and palms and soles, sites the company describes as difficult to treat and likely to reduce patients' quality of life. The most common side effects, each occurring in at least 5% of patients, were upper respiratory infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%); Takeda said no new safety signals turned up.
The drug is a once-daily oral pill that blocks tyrosine kinase 2 (TYK2), an enzyme in the Janus kinase (JAK) family. Takeda says lab testing found zasocitinib is more than a million times more selective for TYK2 than for JAK1, JAK2 or JAK3, the pitch being fewer of the cardiovascular and blood-related risks tied to broader JAK inhibition.
The European Medicines Agency has separately accepted Takeda's marketing application for the same indication and started its own review. The company is also running phase 3 trials of zasocitinib in psoriatic arthritis and phase 2 trials in Crohn's disease, ulcerative colitis, vitiligo and hidradenitis suppurativa, so a US approval would matter well beyond psoriasis.
Takeda said the filing itself has no material effect on its earnings forecast for the year to March 2027. The company puts the global psoriasis population at 66.4 million people, of whom 80% to 90% have the plaque form zasocitinib targets. Investors now wait on a regulator, not a lab.