Rinvoq, which is discovered and developed by AbbVie scientists, is a selective JAK inhibitor that is being studied in many immune-mediated inflammatory diseases.
The regulator has recommended the drug dose of 15mg daily once for adult patients with active nr-axSpA with objective signs of inflammation. These patients have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
The inflammation is indicated by C-reactive protein (CRP) and/or magnetic resonance imaging (MRI).
AbbVie chief medical officer and development vice-president Neil Gallagher said: “Patients with axSpA often experience delayed diagnosis and once they do receive a diagnosis, there are limited therapies available to help control disease symptoms, such as inflammation, back pain and stiffness.
“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need.”
The positive CHMP opinion is supported by data obtained from the Phase III SELECT-AXIS 2 clinical study, which was conducted to evaluate the efficacy and safety of upadacitinib to treat nr-axSpA in adult patients.
In the study, the therapy met the primary endpoint of Assessment of SpondyloArthritis international Society 40% response criteria (ASAS40) as well as the initial 12 of 14 ranked secondary endpoints.
The safety data was also reported with no new risks identified compared to upadacitinib’s known safety profile.
The regulatory decision is expected to come in the third quarter of this year.
At present, upadacitinib is approved in the EU for moderate to severe active rheumatoid arthritis, active ankylosing spondylitis, active psoriatic arthritis, as well as moderate to severe atopic dermatitis.