AbbVie has announced that the European Commission (EC) has granted marketing authorisation for Rinvoq (upadacitinib) for certain patients with moderate to severe active rheumatoid arthritis.
The once-daily selective and reversible JAK inhibitor is indicated for those who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs, and may be used as monotherapy or in combination with methotrexate (MTX), the company disclosed.
The decision is based on results from the Phase III SELECT studies, in which the treatment met all primary and ranked secondary endpoints, demonstrating significantly higher remission rates than both the placebo and blockbuster Humira (adalimumab) arm.
Further, more patients treated with Rinvoq alone achieved remission than those treated with MTX.
Proffessor Andrew Cope, head of the Centre for Rheumatic Diseases at King’s College London said that the results of these studies “mean that patients with active disease have another treatment option with an acceptable safety profile that may induce disease remission even when they have had an inadequate response to drugs such as methotrexate or anti-TNF therapy.”
He continued, “Upadacitinib can be used as a single agent and so could benefit many patients who have struggled to tolerate alternative therapies”.
Earlier this year the drug received authorisation from the US Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to MTX.
Currently, an estimated 400,000 people in the UK are living with rheumatoid arthritis, the majority of whom don’t achieve remission.
