AbbVie granted EU marketing authorisation for new arthritis drug
pharmafile | December 19, 2019 | News story | Business Services | AbbVie, EC, EU, arthritis, rheumatoid arthritis
AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible JAK inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis, who are intolerant of other similar drugs.
It may be used as a monotherapy or in combination with methotrexate.
The EC authorisation of RINVOQ is based on data from a Phase 3 trial which saw 4,400 patients participate.
The studies included assessments of efficacy, safety and tolerability across a variety of patients; including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs, and who were naïve or inadequate responders to MTX
Alice Butler, AbbVie’s UK Medical Director, said: “Over the past two decades important advances in the treatment of rheumatoid arthritis have been made, making clinical remission a possibility for more people living with rheumatoid arthritis. We are proud to have been at the forefront of this and to now be able to offer people with moderate to severe RA a new oral treatment option.”
Across the Phase 3 studies, RINVOQ met all primary and ranked secondary endpoints. It demonstrated consistent efficacy, with or without methotrexate, and achieved consistent remission rates across patient populations studied.
Professor Andrew Cope, Head of the Centre for Rheumatic Diseases at King’s College London, said: “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”.
An estimated 400,000 people in the UK are living with rheumatoid arthritis, the majority of which do not achieve remission. It also affects 1.3 million in America and as much as 1% of the world.
Conor Kavanagh
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