FDA panel votes against approval of J&J arthritis drug

[August 03, 2017] By Toni Clarke

(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 malignancies.

"The safety is not there," said Dr. Beth Jonas, interim head of the division of rheumatology at the University of North Carolina School of Medicine.

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 1.3 million.

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.

"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 different way."

The FDA, in briefing documents released on Monday, noted that the trend toward increased overall mortality seemed unique to the sirukumab program.

(Reporting by Toni Clarke in Washington; Editing by Jonathan Oatis and Steve Orlofsky)

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