FDA Panel Votes Against New Indication for Humira

An FDA advisory panel voted yesterday against recommending that AbbVie’s Humira be approved to treat early-stage spondyloarthritis, a chronic inflammatory rheumatic disease.

A panel of independent FDA advisors voted yesterday to recommend that additional trials be required to prove the efficacy of Humira (adalimumab) to treat non-radiographic axial spondyloarthritis, a joint disease that causes arthritis.

The panelists backed up their recommendation by noting that data collection and analysis during clinical trials for this indication had numerous limitations and citing the size and makeup of the patient subgroups included in the trials as a potential issue. According to an FDA document released in advance of yesterday’s meeting, “Study M10-791 was intended to enroll non-radiographic axial spondyloarthritis patients but in actuality enrolled a subgroup of patients who fulfilled modified New York Criteria for ankylosing spondylitis (AS).” As a result, “A markedly higher proportion of patients in the AS subgroup responded to adalimumab-treatment compared to placebo-treatment and skewed results for the overall group higher.”

The panel voted 12 to 1 against approval for the drug’s expanded indication. Humira is already approved by the FDA to treat rheumatoid arthritis, plaque psoriasis, ulcerative colitis, psoriatic arthritis, Crohn’s Disease, polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis, many of which are considered forms of spondyloarthritis.

Spondyloarthritis is characterized as any joint disease involving the vertebral column that is coupled with inflammation. Ankylosing spondylitis in particular is a disease of the axial skeleton and is the most common form of spondyloarthritis, according to the American College of Rheumatology.

There are currently no drugs approved in the United States to treat patients with axial spondyloarthritis who have had inadequate response to NSAIDs. However, Humira was approved to treat this condition in Europe in July 2012.