Europe's medicines regulator yesterday said it would re-examine its authorisation of Sanofi-Aventis's weight-loss drug Acomplia after a unanimous vote on Wednesday against approval in the US by an advisory panel to the Food & Drug Administration.
News of the fresh doubts, triggered by concern that the medicine - known generically as rimonabant - may cause depression and suicidal thinking, pushed the French pharmaceutical group's shares down by up to 8.5 per cent in Paris and spurred several broker downgrades.
The setback has also prompted some analysts to voice concerns over management's credibility.
"What does surprise us is the dramatic disconnect between Sanofi's persistent optimistic assessment of the FDA regulatory process for rimonabant, and the FDA's clearly negative presentation on the risk benefit assessment of the compound," said Andrew Baum, analyst at Morgan Stanley.
"The outcome of this meeting will raise further concerns in investors' minds over the integrity of Sanofi's guidance to investors."
More at the FT
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