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RegulatoryImmunologyIL-23Regulatory Approval

FDA Accepts Supplement Application for SKYRIZI (Risankizumab) by AbbVie

The FDA's acceptance of the supplemental application for SKYRIZI indicates a potential expansion of AbbVie's market presence in the IL-23 inhibitor segment. This could lead to intensified competition, particularly against established products like Tremfya and Benlysta.

Published: June 18, 2026
Updated: June 18, 2026
Author: Humanexa Intelligence
Therapeutic area: Immunology / IL-23
Company: AbbVie
Asset: SKYRIZI
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval

Company

AbbVie

Asset

SKYRIZI

Indication

Immunology / IL-23

Status

Approved

Signal Score

8.2

Signal assessment

Signal strength

high

Confidence level

moderate

Signalhigh
Confidencemoderate

Strategic implication

The FDA's acceptance of the supplemental application for SKYRIZI indicates a potential expansion of AbbVie's market presence in the IL-23 inhibitor segment. This could lead to intensified competition, particularly against established products like Tremfya and Benlysta.

Why it matters

The FDA's acceptance of the supplemental application for SKYRIZI indicates a potential expansion of AbbVie's market presence in the IL-23 inhibitor segment. This could lead to intensified competition, particularly against established products like Tremfya and Benlysta.

What changed

Regulatory Approval

Analysis

The FDA has accepted a supplemental application for SKYRIZI (Risankizumab) from AbbVie.

The FDA's acceptance of the supplemental application for SKYRIZI indicates a potential expansion of AbbVie's market presence in the IL-23 inhibitor segment. This could lead to intensified competition, particularly against established products like Tremfya and Benlysta.

Monitor the timeline for the FDA's final decision and any subsequent market reactions from competitors.

Related companies & assets

Companies

  • AbbVie →

Assets

  • SKYRIZI →
  • Psoriasis →
  • Immunology →

Sources & Humanexa intelligence

Source links

  • FDA AP — SKYRIZI (SUPPL) ↗
  • FDA Accepts Supplement Application for SKYRIZI (Risankizumab) by AbbVie ↗

Related Humanexa pages

  • FDA Accepts Supplement Application for SKYRIZI (Risankizumab) by AbbVie →

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Asset

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Indication

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Status

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Signal Score

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FDA Grants AP Status for Acetazolamide Sodium ANDA202693

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