STAT+: European regulators consider appeal over Amylyx ALS drug
This week, European regulators are considering an appeal from Amylyx Pharmaceuticals after initially recommending against approving the company’s ALS treatment.
LONDON — This week, European regulators are considering an appeal from Amylyx Pharmaceuticals after initially recommending against approving the company’s ALS treatment — the latest potential turning point for a drug that has seen its share of ups and downs with regulatory bodies.
In June, a European Medicines Agency committee issued a negative review of Amylyx’s drug, called Albrioza, and cast doubt on whether it had demonstrated effectiveness in its pivotal study. That would have almost certainly led to a rejection by regulators, but Amylyx requested what’s called a re-examination of the opinion. On Tuesday, the EMA held a meeting on the appeal, and a decision is expected in the coming weeks.
“There are patients who are dying and they really want access to the drug,” said Evy Reviers, the chairwoman of the European Organization for Professionals and Patients with ALS, whose father has the neurological disease.
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