FDA to decide on Takeda's psoriasis blockbuster hope in Q1

The FDA has started a review of the marketing application for Takeda's TYK2 inhibitor zasocitinib in psoriasis, setting up a decision in mid-March 2027.

If approved, zasocitinib would be the first direct competitor to Bristol Myers Squibb's TYK2 inhibitor Sotyktu (deucravacitinib), which is outperformed as a treatment for moderate-to-severe plaque psoriasis in the LATITUDE Atlas study.

BMS had blockbuster expectations for Sotyktu when it was first launched for psoriasis in 2022, although, sales have been slow to gather momentum, reaching just $291 million worldwide last year. They rose slightly to $156 million in the first six months of 2026, bolstered by a recent FDA approval in psoriatic arthritis.

The FDA has started a priority review of Takeda's drug, which bested Sotyktu on all primary and secondary efficacy endpoints in the head-to-head study – including complete skin clearance, which was 35% and 14%, respectively, at week 16 – with a similar tolerability profile.

Takeda said that zasocitinib has the potential to "redefine oral treatment expectations" in moderate-to-severe plaque psoriasis, as its drug started to diverge from Sotyktu on efficacy within around eight weeks of starting the oral, once-daily 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, Takeda's president of R&D, who has just announced his retirement in June 2027.

"Our phase 3 data demonstrated rapid and durable skin clearance across various patient types and in high-impact and hard-to-treat areas," he added. "Based on the results across nearly 3,000 patients, zasocitinib has the potential to be a leading oral treatment option in psoriasis."

Zasocitinib is one of a new wave of potential product launches that Takeda is relying on to fuel mid-term growth, alongside mezagitamab for chronic autoimmune and kidney diseases, fazirsiran for alpha-1 antitrypsin deficiency-associated liver disease, and elritercept for myelodysplastic syndromes.

All these drugs – along with recent launches, Orzeyful (oveporexton) for narcolepsy and Mimrylo (rusfertide) for polycythemia vera – are expected to help plug a revenue gap at Takeda later this decade as patents expire on its $6 billion-plus blockbuster inflammatory bowel disease drug Entyvio (vedolizumab).

Some analysts have predicted that zasocitinib could eventually reach $5 billion in peak annual sales, provided it also gets approval for additional indications. Takeda is running phase 3 trials of zasocitinib in psoriatic arthritis, with mid-stage studies also underway in Crohn's disease, ulcerative colitis, hidradenitis suppurativa, and vitiligo.