There were four cases of malignancy reported in the baricitinib group and none in the adalimumab group in weeks 0-24. Two deaths were reported in the baricitinib group and none in the other two groups.
FDA must be focusing along the lines of this safety signal. Otherwise, this drug should have been a clear cut approval. We're back to the risk-averse FDA.
JMHO
Recent INCY News
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