View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 2, 2022

FDA grants approval for AbbVie’s Rinvoq to treat ankylosing spondylitis

The approval is based on safety and efficacy findings from the Phase III SELECT-AXIS 2 and Phase II/III SELECT-AXIS 1 trials.

The US Food and Drug Administration (FDA) has granted approval for AbbVie’s Rinvoq (upadacitinib; 15 mg, once daily) to treat adults wsith active ankylosing spondylitis (AS).

The treatment is intended for AS patients who respond inadequately or are intolerant to one or more tumour necrosis factor (TNF) blockers.

A selective Janus kinase (JAK) inhibitor, Rinvoq is being analysed in various immune-mediated inflammatory ailments. 

The latest approval is backed 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 enrolled subjects 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 subjects 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 these trials, treatment with 15mg Rinvoq offered an ASAS40 response in a substantial proportion of subjects, meeting the primary endpoint versus placebo at week 14. 

Furthermore, 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 approval for AS is 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.”

A chronic inflammatory musculoskeletal ailment, AS chiefly impacts the spine and causes debilitating symptoms of inflammatory back pain, stiffness and limited mobility. 

In March this year, the US FDA approved Rinvoq for treating adults with moderate-to-severe active ulcerative colitis.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU