July 23 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
(Reporting by Esha Dey in Bangalore, additional reporting by
Zeba Siddiqui; Editing by Sreejiraj Eluvangal)