Panelists were concerned about an imbalance in the number of deaths in patients taking sirukumab compared with those taking a placebo
THE US 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 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.
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