GlaxoSmithKline and Human Genome fall as US FDA questions lupus drug candidate Benlysta
Ahead of an advisory panel review tomorrow (November 16), the US Food and Drug Administration posted briefing documents that raise questions about the likely approval of Benlysta (belimumab), which is being developed as a treatment for systemic lupus erythematosus by UK drug giant GlaxoSmithKline (LSE: GSK) and USA-based Human Genome Sciences (Nasdaq: HGSI).
The FDA highlighted that “the apparent increased mortality risk with (Benlysta) remains concerning, particularly in light of the marginal efficacy observed.” The papers suggest that the drug showed inconsistent results and “appeared to be associated with an increase in deaths...including three suicides.”
The news on Friday saw GSK’s shares dip 0.5% to £12.23 and HGS dropped 11% to $23.60 by close of normal trading on Friday, having already fallen 14% in the past month.
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