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`SEPTEMBER 22, 2017 / 4:33 PM / 2 YEARS AGO
`
`U.S. FDA rejects J&J's arthritis
`drug
`
`1 M I N R E A D
`
`Sept 22 (Reuters) - The U.S. Food and Drug Administration has
`declined to approve Johnson & Johnson’s rheumatoid arthritis drug
`sirukumab, saying additional clinical data is needed to further
`evaluate its safety, the company said on Friday.
`
`The FDA’s decision is in keeping with an advisory panel’s
`recommendation in August that the FDA reject the drug. Panelists
`
`https://www.reuters.com/article/johnsonjohnson-arthritis/u-s-fda-rejects-jjs-arthritis-drug-i...
`
`7/21/2019
`
`Lassen - Exhibit 1064, p. 1
`
`
`
`U.S. FDA rejects J&J's arthritis drug - Reuters
`
`Page 2
`
`were concerned about 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.
`
`Reporting by Toni Clarke in Washington; Editing by Lisa Shumaker
`Our Standards: The Thomson Reuters Trust Principles.
`
`https://www.reuters.com/article/johnsonjohnson-arthritis/u-s-fda-rejects-jjs-arthritis-drug-i...
`
`7/21/2019
`
`Lassen - Exhibit 1064, p. 2
`
`
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