The EC approval is supported by data from the Phase 3 SELECT-AXIS 2 clinical trial, in which Rinvoq delivered meaningful disease control with nearly half of nr-axSpA patients achieving ASAS40 compared to placebo
AbbVie has received the European Commission (EC) approval for its JAK inhibitor therapy Rinvoq (upadacitinib15mg) to treat a type of axial spondyloarthritis in adults.
The oral therapy is indicated for active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, for whom NSAIDs are ineffective.
The signs of inflammation include elevated C-reactive protein (CRP) and magnetic resonance imaging (MRI).
Rinvoq is a selective and reversible JAK inhibitor, discovered and developed by AbbVie, and is being evaluated in several immune-mediated inflammatory diseases.
It has been approved in several countries for indications including ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis.
Last week, the drug was approved by the EC to treat active ulcerative colitis in adults, who are intolerant to either conventional therapy or a biological agent.
With the current authorisation, Rinvoq is now approved for nr-axSpA in all member states of the European Union (EU), along with Iceland, Liechtenstein, Northern Ireland and Norway.
AbbVie research and development senior vice president and chief scientific officer Thomas Hudson said: “For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine.
“AbbVie is proud to offer RINVOQ as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs.
“RINVOQ is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis.”
Axial Spondyloarthritis axSpA is a chronic, progressive and debilitating inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness.
It is prevalent in the forms of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA), and non-radiographic axial spondyloarthritis (nr-axSpA).
The EC approval is supported by results from the Phase 3 SELECT-AXIS 2 nr-axSpA clinical trial, in which Rinvoq 15mg achieved superior response (ASAS40) compared to placebo.
The drug has achieved statistical significance in 12 of the 14 multiplicity-controlled secondary endpoints compared to placebo at week 14.
Rinvoq has also shown safety data that was consistent with the known safety profile of the drug, with no new risks identified.
SELECT-AXIS 2 investigator Filip Van den Bosch said: “The European Commission’s approval of Rinvoq for the treatment of nr-axSpA offers physicians in the European Union an important new therapeutic option with proven efficacy in both nr-axSpA and AS patient populations.
“Living with nr-axSpA can pose many challenges and significantly impact a patient’s quality of life. Early and effective disease management of patients with active nr-axSpA is key to improving health outcomes.”
In a separate development, AbbVie has entered into a $2.37bn settlement to resolve numerous lawsuits against its Irish unit Allergan for marketing opioid painkillers in the US.
If confirmed, the settlement is anticipated to clear more than 3,000 complaints against the company, filed by the state and local governments across the country.
Last month, Allergan and Israeli drugmaker Teva Pharmaceuticals entered into a $58m deal with the city of San Francisco to settle the claims over their role in the Opioid crisis.