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First TYK2 inhibitor reaches FDA decision for psoriatic arthritis

First TYK2 inhibitor reaches FDA decision for psoriatic arthritis

New Capabilities
By Newzino Staff |

Bristol Myers Squibb's Sotyktu could open a new drug class for 1.5 million Americans with the joint disease

Today: FDA reaches PDUFA decision deadline

Overview

For most of the past decade, people with psoriatic arthritis who wanted a pill instead of an injection had one real option: Janus kinase (JAK) inhibitors, a class of oral drugs that the Food and Drug Administration (FDA) slapped with its strongest safety warning in 2021 after a major trial linked them to higher rates of heart attacks, blood clots, cancer, and death. On March 6, the FDA reached its decision deadline on whether to approve the first oral drug from a different class entirely—Bristol Myers Squibb's Sotyktu (deucravacitinib), a selective tyrosine kinase 2 (TYK2) inhibitor—for adults with active psoriatic arthritis, a condition that causes painful joint inflammation in roughly 1.5 million Americans.

In This Story

3 Videos
2 People
Christopher Boerner
PM
3 Orgs
Bristol Myers Squibb U.S. Food and Drug Administration Takeda Pharmaceutical Company Limited
8 Events
4 Key Stats
54.2%
3 Scenarios
FDA approves Sotyktu for psoriatic arthritis, opening new drug class
2 Context
Tofacitinib (Xeljanz) approval for rheumatoid arthritis (2012)

Key Indicators

54.2%
ACR20 response at 16 weeks
Percentage of patients on deucravacitinib achieving at least 20% improvement in joint symptoms, versus 34.1% on placebo
1.5M
Americans with psoriatic arthritis
Estimated number of adults in the United States living with psoriatic arthritis
$4B
Projected peak annual sales
Bristol Myers Squibb's target peak revenue for Sotyktu across all approved indications
19%
Sotyktu revenue growth in 2025
Year-over-year sales growth for the drug's existing plaque psoriasis indication

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People Involved

Christopher Boerner
Christopher Boerner
Board Chair and Chief Executive Officer, Bristol Myers Squibb (Leading BMS through portfolio transition toward growth brands)
PM
Philip J. Mease
Rheumatologist, Swedish Medical Center; POETYK trial investigator (Active clinical researcher in psoriatic arthritis therapeutics)

Organizations Involved

Bristol Myers Squibb
Bristol Myers Squibb
Pharmaceutical Company
Status: Awaiting FDA decision on Sotyktu expansion into psoriatic arthritis

A global biopharmaceutical company that discovered and developed deucravacitinib internally, marking it as the first selective TYK2 inhibitor to reach market.

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal Regulatory Agency
Status: Reached PDUFA decision deadline on Sotyktu for psoriatic arthritis

The federal agency responsible for evaluating and approving prescription drugs in the United States, including new indications for already-marketed medicines.

Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited
Pharmaceutical Company
Status: Developing competing TYK2 inhibitor zasocitinib (TAK-279) in Phase 3

A global pharmaceutical company developing zasocitinib, a next-generation TYK2 inhibitor that claims stronger and more sustained enzyme inhibition than deucravacitinib.

Timeline

  1. FDA reaches PDUFA decision deadline

    Regulatory

    The FDA reached its Prescription Drug User Fee Act target action date for Sotyktu's supplemental application in psoriatic arthritis. If approved, deucravacitinib would become the first TYK2 inhibitor indicated for the joint condition.

  2. Survey: one-third of rheumatologists see Sotyktu as substantial advance

    Market Analysis

    A Spherix Global Insights survey found that one in three rheumatologists viewed Sotyktu as a substantial advance for patients with psoriatic arthritis, ahead of the March 6 FDA decision deadline.

  3. FDA accepts application for psoriatic arthritis

    Regulatory

    The FDA accepted Bristol Myers Squibb's supplemental new drug application to expand Sotyktu's label to include treatment of adults with active psoriatic arthritis. Regulatory agencies in three other global regions also accepted the application for review.

  4. 52-week data show sustained responses

    Clinical Trial

    Longer-term data presented at medical conferences showed 63.1% of patients on deucravacitinib maintained ACR20 responses through 52 weeks, with no new safety signals and low rates of serious adverse events.

  5. Phase 3 psoriatic arthritis trials report positive results

    Clinical Trial

    Bristol Myers Squibb announced that both POETYK PsA-1 and POETYK PsA-2 met their primary endpoints, with 54.2% of deucravacitinib patients achieving at least 20% improvement in joint symptoms at 16 weeks, compared with 34.1% and 39.4% on placebo respectively.

  6. FDA approves first TYK2 inhibitor for plaque psoriasis

    Regulatory

    The FDA approved Sotyktu (deucravacitinib), the first selective TYK2 inhibitor, for adults with moderate-to-severe plaque psoriasis. The drug offered a new oral mechanism distinct from JAK inhibitors and free of the class's black box warning.

  7. FDA adds strongest safety warning to JAK inhibitors

    Regulatory

    The FDA required black box warnings on all JAK inhibitors approved for inflammatory conditions after the ORAL Surveillance trial linked tofacitinib to increased rates of heart attacks, blood clots, cancer, and death compared with tumor necrosis factor (TNF) inhibitors.

  8. First oral JAK inhibitor approved for arthritis

    Regulatory

    The FDA approved tofacitinib (Xeljanz), the first oral Janus kinase inhibitor, for rheumatoid arthritis, establishing oral targeted therapy as a viable alternative to injected biologics.

Scenarios

1

FDA approves Sotyktu for psoriatic arthritis, opening new drug class

Discussed by: Rheumatology Advisor, The Rheumatologist, and multiple industry analysts who note the clean safety profile and lack of an advisory committee meeting as positive signals

The FDA approves deucravacitinib for adults with active psoriatic arthritis without major label restrictions. Rheumatologists gain access to the first oral TYK2 inhibitor for the condition, positioned as an alternative for patients who need an oral therapy but face the black box warnings attached to JAK inhibitors. Bristol Myers Squibb begins marketing to both dermatologists and rheumatologists. Sales growth accelerates toward the company's $4 billion peak target, though competition from Takeda's zasocitinib looms within two to three years.

2

FDA approves with restrictions or additional safety monitoring requirements

Discussed by: Industry analysts who note the precedent of FDA caution with oral immunomodulators following the ORAL Surveillance JAK inhibitor findings

The FDA approves Sotyktu for psoriatic arthritis but adds post-marketing study requirements or label language that limits prescribing to patients who have failed other therapies. This would narrow the initial addressable market and slow adoption compared with an unrestricted approval, though it would still establish the TYK2 class in rheumatology.

3

FDA issues complete response letter, requests additional data

Discussed by: Cautious analysts who point to the modest effect size over placebo and the general FDA scrutiny of oral immunomodulators

The FDA declines to approve the psoriatic arthritis indication in its current form and requests additional clinical data or clarification on specific efficacy or safety questions. This would delay the indication by a year or more, allow Takeda's zasocitinib to close the competitive gap, and pressure Bristol Myers Squibb's growth portfolio projections. The drug's existing psoriasis indication would remain unaffected.

Historical Context

Tofacitinib (Xeljanz) approval for rheumatoid arthritis (2012)

November 2012

What Happened

The FDA approved tofacitinib, the first oral Janus kinase inhibitor, for rheumatoid arthritis. Developed by Pfizer, it represented a landmark shift: patients with inflammatory arthritis could take a pill instead of receiving injections of biologic drugs like adalimumab (Humira). Tofacitinib later won approvals for psoriatic arthritis and ulcerative colitis.

Outcome

Short Term

Tofacitinib rapidly gained market share as patients and rheumatologists embraced the convenience of oral dosing. Pfizer projected billions in peak sales.

Long Term

The 2021 ORAL Surveillance trial revealed increased cardiovascular, cancer, and blood clot risks compared with TNF inhibitors, triggering FDA black box warnings across the entire JAK inhibitor class and dramatically limiting their prescribing. The safety setback created the very market gap that TYK2 inhibitors now aim to fill.

Why It's Relevant Today

Deucravacitinib's path directly echoes tofacitinib's: a first-in-class oral inhibitor expanding from one autoimmune condition into arthritis. But its regulatory story is shaped by the JAK inhibitor safety fallout—TYK2's selective mechanism is specifically designed to avoid the risks that derailed its predecessors.

Adalimumab (Humira) expansion into psoriatic arthritis (2005)

2005

What Happened

Three years after its initial approval for rheumatoid arthritis, the FDA expanded adalimumab's label to include psoriatic arthritis. The TNF inhibitor, made by Abbott Laboratories (later AbbVie), became the first biologic broadly used across both skin and joint manifestations of psoriatic disease. It eventually won approval for over a dozen conditions.

Outcome

Short Term

The psoriatic arthritis approval significantly expanded adalimumab's addressable market and helped establish biologics as standard care for moderate-to-severe psoriatic disease.

Long Term

Adalimumab became the world's best-selling drug, reaching $21 billion in annual sales at its peak. Its success proved that expanding an approved drug into adjacent autoimmune conditions could transform a treatment's commercial trajectory—the same strategy Bristol Myers Squibb is now pursuing with Sotyktu.

Why It's Relevant Today

Bristol Myers Squibb is following the proven playbook of label expansion from skin disease into joint disease. If Sotyktu's psoriatic arthritis approval succeeds, the company will likely pursue further indications such as Crohn's disease, mirroring the multi-indication strategy that made Humira a blockbuster.

Sources

(10)
+4
Bristol Myers Squibb Spherix Global Insights via GlobeNewsWire BioSpace U.S. Food and Drug Administration The Rheumatologist Cleveland Clinic Journal of Medicine MedCentral Rheumatology Live Bristol Myers Squibb Bristol Myers Squibb