The FDA approval is supported by safety and efficacy findings from the Phase III SELECT-AXIS 2 and Phase II/III SELECT-AXIS 1 clinical trials of Rinvoq
AbbVie US Headquarters. (Credit: AbbVie Inc.)
AbbVie has received approval from the US Food and Drug Administration (FDA) for its Rinvoq (upadacitinib; 15 mg, once daily) to treat adults with active ankylosing spondylitis (AS).
The oral treatment is intended for AS patients who respond inadequately or are intolerant to one or more tumour necrosis factor (TNF) blockers.
Rinvoq is a selective Janus kinase (JAK) inhibitor and is being analysed in several immune-mediated inflammatory ailments.
The FDA approval is supported by safety and efficacy findings from the Phase III SELECT-AXIS 2 and Phase II/III SELECT-AXIS 1 clinical trials of Rinvoq.
The SELECT-AXIS 2 trial recruited patients who had an inadequate response or were intolerant to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs) while the SELECT-AXIS 1 enrolled patients who were bDMARD-naïve and had an insufficient response or are not tolerant to a minimum of two nonsteroidal anti-inflammatory drugs (NSAIDs).
In both the studies, treatment with 15mg Rinvoq delivered an ASAS40 response in a substantial proportion of subjects, meeting the primary endpoint versus placebo at week 14.
Additionally, clinical responses were reported by the fourth week for ASAS40 in the SELECT-AXIS 2 trial.
Treatment with Rinvoq offered substantial improvement in AS signs and symptoms at week 14.
The latest FDA clearance for AS represents the fifth indication for Rinvoq in chronic immune-mediated diseases.
AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson said: “Ankylosing spondylitis is a debilitating disease that often affects younger adults and, over time, can result in lasting structural damage that can take an emotional toll on a patient’s life.
“This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases.”
AS is a chronic inflammatory musculoskeletal ailment that mainly impacts the spine and causes debilitating symptoms of inflammatory back pain, stiffness and limited mobility.
In March this year, the US regulator approved Rinvoq to treat adults with moderate-to-severe active ulcerative colitis.