FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis

AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine.

The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis.

The ankylosing spondylitis indication is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 respons…

Read more
  • 0

AbbVie’s Rinvoq met primary endpoint in ankylosing spondylitis trial 

AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae.

The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD) therapy.

Rinvoq is a Janus kinase (JAK) inhibitor presently FDA indicated for moderately to severely active rheumatoid arthritis patients. The FDA indication specifically covers patients with a prior history of inadequate response or intolerance to the immunosuppressive drug methotrexate.

The study used the Assessment in SpondyloArthritis International Society (ASAS) 40 response by week 14 as a primary endpoint.

A total of 45% of Rinvoq recipients achieved an ASAS40 score at week 14 compared to 18% of placebo recipients. Similarly, 44% of…

Read more
  • 0