panel votes against approval of J&J arthritis drug
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[August 03, 2017] By
(Reuters) - The benefits of Johnson &
Johnson's experimental rheumatoid arthritis drug sirukumab do not
outweigh the risks, an advisory panel to the U.S. Food and Drug
Administration concluded on Wednesday.
The panel voted 12-1 that the drug should not be approved, citing
safety concerns, including an imbalance in the number of deaths in
patients taking sirukumab compared with those taking a placebo. The
most common causes of death were major heart problems, infection and
"The safety is not there," said Dr. Beth Jonas, interim head of the
division of rheumatology at the University of North Carolina School
The FDA is not obliged to act on the recommendation of its advisory
panels but typically does so.
J&J originally developed the drug with GlaxoSmithKline Plc. GSK
recently said it would return all rights to J&J. GSK held rights to
the drug in North, Central and South America.
Sirukumab blocks a cytokine in the body known as interleukin 6
(IL-6) that can contribute to the inflammation associated with
rheumatoid arthritis, an autoimmune disorder that affects more than
Panelists said they were especially reluctant to recommend approval
of sirukumab because there are two other drugs on the market in the
same class. These are Roche Holding AG's Actemra and Sanofi SA and
Regeneron Pharmaceuticals Inc.'s <REGN.O Kevzara.
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"If this was a new agent I would probably be a little more
enthusiastic," said Dr. Maria Suarez-Almazor, rheumatology section
chief at the University of Texas MD Anderson Cancer Center. "There
is no reason to think that this new drug will act in a tremendously
The FDA, in briefing documents released on Monday, noted that the
trend toward increased overall mortality seemed unique to the
(Reporting by Toni Clarke in Washington; Editing by Jonathan Oatis
and Steve Orlofsky)
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