AbbVie's Humira (adalimumab), a rheumatoid arthritis drug, has been rejected by the US FDA advisors for use in the treatment of a spinal inflammatory disease, non-radiographic axial spondyloarthritis.
The FDA's Arthritis Advisory Committee voted 12-one against approving Humira for the extended indication, reported Reuters.
The regulatory agency noted that in the trials design application, the company did not provide long-term data to help evaluate Humira's safety profile in the different axial spondyloarthritis subgroups.
The company has been ordered to perform additional studies with the drug to indicate it to treat patients, who have had an inadequate response to, or are intolerant to, a non-steroidal anti-inflammatory drug.
In 2012, the European Commission cleared Humira for axial spondyloarthritis, while it is approved for ankylosing spondylitis in the US.
