STAT+: European regulators once again recommend Amylyx’s ALS drug be rejected
LONDON — European regulators on Friday reiterated their view that an ALS treatment from Amylyx Pharmaceuticals should not be approved, likely dooming the drug’s chances for now.
A European Medicines Agency committee had initially recommended against approving the drug, known as Albrioza, in June. Friday’s confirmation of that position came after the company appealed the decision. While the European Commission officially decides whether to approve a new medicine, it almost always follows the committee’s guidance. The final decision is expected to be made before the end of the year.
The drug, which won approval last year in the United States and is marketed Relyvrio, is designed to slow the progression of the fatal neurological condition. In its pivotal trial, patients who received the drug over 24 weeks scored about two points better on a 48-point scale of symptoms than those who got a placebo, indicating the drug slowed disease progression.
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