The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for AbbVie’s RINVOQ™( Upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who haven’t responded well or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). This positive opinion is for the use of Upadacitinib as monotherapy or in combination with methotrexate.
Why did the EMA CHMP Make a Favorable Opinion?
Their positive opinion is supported by data from the global Phase 3 SELECT rheumatoid arthritis program, evaluating more than 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies. The American biopharmaceutical manufacturer reported that across all five trials—SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY—all primary and ranked secondary endpoints were met, including low disease activity based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) ≤ 3.2, clinical remission based on DAS28-CRP<2.6 and ACR20/50 (depending on study design); improved response was seen with upadacitinib both as monotherapy and in combination with conventional synthetic DMARDs compared to placebo, methotrexate or adalimumab (depending on study design). Data from the SELECT program showed a consistent safety profile across the five studies. The most frequently reported adverse reactions were infections.
Affecting an estimated 23.7 million people worldwide, many people still live with the disease and do not achieve remission. AbbVie invested heavily in the SELECT program to target this articulated unmet need.
In Europe, the European League Against Rheumatism recently commissioned a study that revealed there are significant gaps in essential rheumatoid arthritis care across Europe and between European countries. Costs of rheumatoid arthritis across Europe are significant and the total number afflicted could be 2.3 million.
The Opinion Triggers Approval Process within 67 Days
The CHMP positive opinion represents a scientific recommendation for marketing authorization to the European Commission. The Marketing Authorization would be valid in all member states of the European Union. The Marketing Authorization would be valid in member states of the EU, as well as Iceland, Liechtenstein and Norway. The Commission will make its actual decision within 67 days following the CHMP opinion.
More on Upadacitinib (RINVOQ)
The drug, also known as (ABT-494), is a JAK1 selective inhibitor being investigated to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, atopic dermatitis, psoriatic arthritis, axial SpA and Giant Cell Arteritis.
The FDA safety label is included here.
Roy M. Flesichmann, MD, was the primary investigator for SELECT-COMPARE and is also a clinical professor at the University of Texas Southwestern Medical Center at Dallas. He would certainly be a key opinion leader as the benefits of the treatment.
Call to Action: For adults in Europe that have moderate to severe active rheumatoid arthritis who haven’t responded well or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), consider this drug if the authorities approve the marketing authorization.