STAT+: European regulatory panel weighing against approval of Amylyx’s ALS therapy, company says
A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday.
LONDON — A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday, threatening the drug’s chances of entering the European market.
In a statement, Amylyx said it had learned that a European Medicines Agency’s committee “is trending toward a negative opinion” on the drug, AMX0035, after its May meeting last week.
The committee is expected to issue its formal opinion next month, a recommendation that then goes to the European Commission, which makes the final authorization decision. The commission typically follows the committee’s guidance.
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