Rinvoq now approved by FDA for adults with active AS

The Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib; 15mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, marking the fourth approval for the drug in the past five months alone.

"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," said Dr Thomas Hudson, senior vice president, research and development, chief scientific officer of US biotech AbbVie (NYSE: ABBV), which markets the drug. "This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases," he added.

The FDA approval in AS is supported by efficacy and safety data from the Phase III SELECT-AXIS 2 clinical trial (Study 1) evaluating Rinvoq in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs) and the Phase II/III SELECT-AXIS 1 clinical trial evaluating Rinvoq in patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).