AbbVie submits applications for Upadacitinib in to US FDA and EMA

AbbVie has submitted applications seeking approvals for Upadacitinib to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). The applications are supported by the phase-III Select-Axis 2 (study II) clinical trial, the company notified via a statement.

In the trial study, evaluating the efficacy and safety of Upadacitinib in adult patients with nr-axSpA, Upadacitinib met its primary and most-ranked secondary endpoints. Treatment with Upadacitinib 15 mg once daily resulted in reductions in signs and symptoms of nr-axSpA, including back pain and inflammation, as well as improvements in physical function and disease activity at week 14 versus placebo.

“Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life,” said Thomas Hudson, MD, Senior Vice President, Research and Development, Chief Scientific Officer, AbbVie.

He aded, “AbbVie is committed to working with the FDA and EMA to make Upadacitinib available as a treatment option for patients living with this disease.”

In addition, AbbVie has requested label enhancements for Upadacitinib in the European Union (EU) to include adult patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs), based on the results of the phase-III Select-Axis 2 clinical trial (study 1), as well as two-year results of the phase-II/III Select-Axis 1 clinical trial. The company also provided these data to the FDA in support of the agency’s ongoing review of the supplemental New Drug Application (sNDA) for Upadacitinib in AS, added the statement.

The safety data observed in these patients with AS or nr-axSpA were generally consistent with the known safety profile of Upadacitinib. No new safety risks were identified, the statement concluded.