STAT+: EU poised to reject Amylyx’s ALS drug, as the company vows an appeal
European regulators are on the verge of rejecting an ALS drug from Amylyx Pharmaceuticals, all but dooming the medicine’s chances of entering the E.U. market for now.
LONDON — European regulators are on the verge of rejecting an ALS drug from Amylyx Pharmaceuticals, all but dooming the medicine’s chances of entering the E.U. market for now.
The negative recommendation issued Friday by a European Medicines Agency committee is not a surprise. Last month, Amylyx said that the agency was headed toward a negative review. But it amounts to a serious blow to the drug, which last year won U.S. and Canadian authorization, and is likely to stoke the debate about whether the medicine is truly effective.
“The agency had concerns that the main study did not show convincingly that Albrioza was effective in slowing down the worsening of the disease,” the EMA’s review found. “Data on survival were also not reliable, given the way the data were collected and analyzed.”
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