CHMP recommends treatment for adults with chronic inflammatory disease
pharmafile | June 27, 2022 | News story | Sales and Marketing |
The CHMP has recommended upadacitinib (RINVOQ® 15 mg, once daily) for approval, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) spectrum.
The treatment from AbbVie has been recommended for adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
An EC decision is expected in the third quarter of 2022, AbbVie shared.
“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,” said Neil Gallagher, MD, PhD, Vice President, development, chief medical officer, AbbVie. “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.”
Ax SpA is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage. It consists of two subsets that have been clinically defined as radiographic axial SpA (ankylosing spondylitis) and non-radiographic axial spondyloarthritis (nr-axSpA).
The application for the approval of upadacitinib in nr-axSpA is supported by results from the Phase III SELECT-AXIS 2 study. In the study, upadacitinib met the primary endpoint of Assessment of SpondyloArthritis international Society 40 percent response criteria (ASAS40), and the first 12 of 14 ranked secondary endpoints. No new risks were identified with the treatment compared to the known safety profile of upadacitinib.
Currently, upadacitinib is approved for use in the EU in patients with moderate to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis.
