AbbVie’s Humira Rejected by FDA for Axial Spondyloarthritis
An advisory panel to the US Food and Drug Administration (FDA) have rejected AbbVie’s Humira (adalimumab) for the treatment of a spinal inflammatory disease.
AbbVie are planning to expand the drug’s existing indication for ankylosing spondylitis to include the treatment of non-radiographic axial spondyloarthritis, an inflammatory disease characterised by back pain.
However, yesterday’s meeting of the Arthritis Advisory Committee voted 12-1 against approving Humira for axial spondyloarthritis.
Official documents on the regulatory body’s website prior to the consultation had cast doubt over the design of trials submitted for consideration.
Long-term data was not provided within the submission that would enable the panel to decide on the safety profile for Humira over time in the different axial spondyloarthritis subgroups, the documents noted.
Advisors have reportedly requested additional clinical trials to be conducted to help determine whether Humira should be used to treat patients with the condition who have had an inadequate response to, or are intolerant to, a non-steroidal anti-inflammatory drug.
Interestingly, the European Commission approved Humira for axial spondyloarthritis in 2012, making it the only approved medication available for the condition.
In the US, Humira has already been approved for ankylosing spondylitis, and is also licensed to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s Disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis and ulcerative colitis.