CHMP Recommends Approval of RINVOQ (upadacitinib) for the Treatment of Atopic Dermatitis

AbbVie recently announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of RINVOQ (upadacitinib), an oral, selective and reversible JAK inhibitor, for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. RINVOQ is being studied in several immune-mediated inflammatory diseases.

The CHMP positive opinion was supported by data from the global Phase 3 program evaluating more than 2,500 patients with moderate-to-severe atopic dermatitis across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up. Across the three studies, both doses of RINVOQ met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and reduction in itch compared to placebo at week 16 and other time points (p<0.001) in patients with moderate to severe atopic dermatitis. The most commonly reported adverse events in patients treated with RINVOQ were acne, nasopharyngitis, and upper respiratory tract infections.

“This milestone is an important step forward in our journey to improve care for people living with atopic dermatitis,” said Michael Severino, MD, Vice Chairman and President, AbbVie. “Despite available treatments, many people with moderate-to-severe forms of this disease continue to experience a relentless and burdensome cycle of skin and itch symptoms. We are encouraged that the CHMP has recognized RINVOQ’s potential as an additional treatment option for these patients.”

The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. If approved, this will be the fourth indication for RINVOQ, and RINVOQ will be the first JAK inhibitor in the European Union to treat moderate to severe atopic dermatitis in both adults and adolescents 12 years and older.

Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin. It affects up to an estimated 10% of adults and 25% of children. Between 20% 46% of adults with atopic dermatitis have moderate-to-severe disease. The range of symptoms poses significant physical, psychological, and economic burden on individuals impacted by the disease.

The global Phase 3 program evaluated more than 2,500 patients worldwide across three global pivotal studies: Measure Up 1, Measure Up 2, and AD Up. The studies evaluated the efficacy and safety of RINVOQ (15 mg and 30 mg, once daily), with and without topical corticosteroids (TCS), in adults and adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy. The co-primary endpoints across all three studies were at least a 75% improvement in Eczema Area and Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score 0/1 at week 16. Secondary endpoints included reduction of itch defined as ≥4 point improvement in Worst Pruritus Numerical Rating Scale (NRS) from baseline at week 16 and other timepoints, as well as EASI 90 and EASI 100 at week 16. More information on this program can be found at www.clinicaltrials.gov (NCT03569293, NCT03607422, NCT03568318).

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. In August 2019, RINVOQ received US FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in these indications is 15 mg. Phase 3 trials of RINVOQ in axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis are ongoing. Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy are under evaluation by regulatory authorities.

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.