(Reuters) - An advisory panel to the U.S. Food and Drug Administration voted against approving AbbVie Inc’s rheumatoid arthritis drug Humira for treating an inflammatory disease of the spine.
The panel of independent advisors called for additional trials to prove the efficacy of the drug in treating early-stages of spondyloarthritis.
The FDA will take the panel’s 12 to 1 vote into consideration while deciding upon the final approval for this new use for the drug.
Ahead of Tuesday’s panel meet, FDA staff had put out documents questioning the design of the trial.
Shares of AbbVie, the former branded prescription drugs business of Abbott Laboratories, fell 1 percent to $44.37 in midday trade on the New York Stock Exchange.
Patients suffering from non-radiographic axial spondyloarthritis have acute back pain, but the damages to their lower back do not always show up on an X-ray.
AbbVie is trying to get Humira approved for treating patients who have failed to respond to other drugs.
Chemically called adalimumab, Humira is already approved for multiple uses including rheumatoid arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis. It brought in $9.27 billion in annual sales last year.
Reporting by Esha Dey in Bangalore, additional reporting by Zeba Siddiqui; Editing by Sreejiraj Eluvangal