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European Commission approves AbbVie’s Rinvoq for atopic dermatitis

The European Commission (EC) has approved AbbVie's Rinvoq (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who are candidates for systemic therapy.

The European Commission (EC) has approved AbbVie’s Rinvoq (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who are candidates for systemic therapy.

Rinvoq, which is discovered and developed by AbbVie scientists, is an oral, selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.

The EC recommended drug dose for atopic dermatitis in adults is 15mg or 30mg daily once depending on individual patient presentation.

For adolescents aged 12 to 17 and adults aged 65 years and above, the recommended dose is 15mg once daily.

The approval is based on Phase III studies conducted on more than 2,500 adults and adolescents with moderate to severe atopic dermatitis.

Across these studies, Rinvoq met all the primary and secondary endpoints, showing rapid and significant improvement in skin clearance and itch reduction compared to placebo.

AbbVie claimed that Rinvoq is the first JAK inhibitor approved in the European Union (EU) to treat atopic dermatitis.

25 AUG 2021

https://www.pharmaceutical-business-review.com/

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