Fibrogen presented new clinical trial data on Friday that alleviates concerns about the heart safety of its experimental anemia pill, the drugmaker said.
A pooled safety analysis of approximately 8,000 kidney disease patients enrolled in six Phase 3 clinical trials concluded that the risk of an adverse cardiovascular event — heart attacks, strokes, death, and chest pain — was statistically comparable between the Fibrogen drug called roxadustat and either a placebo or a currently approved anemia injection used as a control.
Last May, Fibrogen offered less-than-reassuring and confusing statements about the heart safety of roxadustat without disclosing actual clinical data. That muddled performance sent Fibrogen’s stock price sliding on fears that a safety flaw might keep roxadustat from reaching the market.
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