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
Trinity College Dublin, Ireland, dermatology professor Alan Irvine said: “As a dermatologist researching and treating atopic dermatitis for more than 25 years, I’ve seen first-hand the debilitating impact this disease can have on a person’s daily life.
“Clinicians need more tools to help them treat and manage this complex disease. The degree and early onset of skin clearance and itch relief in the RINVOQ Phase 3 clinical studies are very encouraging. The outcomes have the potential to advance treatment goals for patients with moderate to severe atopic dermatitis.”
This approval represents fourth EC-approved indication for Rinvoq, which is now approved in all EU member states including Iceland, Liechtenstein, Norway and Northern Ireland.
The drug is also approved in Russia, Saudi Arabia, United Arab Emirates, New Zealand and Chile.
European regulators had previously approved Rinvoq 15mg for adults with moderate to severe active rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.