AbbVie submits applications for treatment of chronic disease

AbbVie has announced the submission of applications seeking the approval of upadacitinib, (RINVOQ®, 15 mg once daily) 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 submissions to the FDA and EMA are supported by the Phase III SELECT-AXIS 2 (Study 2) clinical trial.

Axial Spondyloarthritis (axSpA) is a chronic, inflammatory rheumatic disease that affects the axial skeleton, causing severe pain, stiffness and fatigue. The disease typically starts in early adulthood, affecting education and career trajectory for those suffering.

“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 of research and development, chief scientific officer, AbbVie. “AbbVie is committed to working with the FDA and EMA to make upadacitinib available as a treatment option for patients living with this disease.”

Many axial spondyloarthritis patients often experience other manifestations of disease, such as enthesitis, peripheral arthritis, dactylitis, uveitis, psoriasis, inflammatory bowel disease and osteoporosis. Enthesitis is the inflammation of the ‘enthesis,’ where a tendon or ligament attaches to bone. Symptoms include pain and swelling. Dactylitis is inflammation of fingers or toes, and Uveitis is a form of eye inflammation.

AbbVie has also 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). This request is 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.

AbbVie 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.

Ana Ovey