Why did the European Commission grant approval to AbbVie (NYSE:ABBV)?

The European Commission approved AbbVie (NYSE:ABBV) because Phase 3 data demonstrated that its drug SKYRIZI is safe and effective for pediatric patients. The decision offers a new systemic therapy option for children aged six years and older with moderate to severe plaque psoriasis.

What specific formulation is AbbVie (NYSE:ABBV) introducing for smaller patients?

AbbVie (NYSE:ABBV) is introducing a 55 mg pre-filled syringe formulation. This specific dosage is designed for pediatric patients who weigh less than 40 kg.

How many pediatric patients participated in the AbbVie (NYSE:ABBV) safety evaluation?

A total of 137 pediatric patients were evaluated in the clinical safety profile managed by AbbVie (NYSE:ABBV). The observed data showed no new safety signals and remained entirely consistent with adult profiles.

What clinical trial data supported this decision for AbbVie (NYSE:ABBV)?

The regulatory decision for AbbVie (NYSE:ABBV) was fully backed by data from the Phase 3 OptIMMize-1 and OptIMMize-2 clinical trials. These studies confirmed the safety and efficacy metrics required for pediatric authorization.

What is the geographic market impact of this authorization for AbbVie (NYSE:ABBV)?

This authorization allows AbbVie (NYSE:ABBV) to market its plaque psoriasis treatment to children and adolescents across all European Commission member states. The decision broadens the company's geographical commercial scope for pediatric immunology.

Image for illustrative purposes only. Not a real photo.

AbbVie receives EU approval for SKYRIZI in children

Written by Brie CarterPublished Jun 23, 2026, 7:57 AM

The European Commission approved AbbVie's SKYRIZI for pediatric patients aged six and older with moderate to severe plaque psoriasis.
The market expansion introduces a new 55 mg pre-filled syringe formulation for patients weighing under 40 kg.
The approval expands the treatment portfolio for AbbVie by leveraging successful adult Phase 3 clinical trial data.

AbbVie (NYSE:ABBV) secured European Commission approval for SKYRIZI to treat pediatric plaque psoriasis patients aged six and older.

This regulatory milestone expands the therapeutic reach of the treatment beyond the previously established adult demographic.

The clearance introduces a 55 mg pre-filled syringe specifically designed for children weighing less than 40 kg.

Clinical data from Phase 3 trials evaluated 137 pediatric subjects and demonstrated safety metrics consistent with adult profiles.

Following the announcement, AbbVie's share price was unchanged at $170.

The company stated that this development aligns with its strategy to scale immunology treatments across multiple age brackets.

This market move builds on previous clinical milestones aimed at addressing unmet needs in chronic dermatological conditions.

AbbVie receives EU approval for SKYRIZI in children

Frequently asked questions

Assets related to this article