Amylyx’s Relyvrio/Albrozia for treating amyotrophic lateral sclerosis was refused approval in the EU but was approved in the US before it was withdrawn following poor Phase III study results.
In the US, a more discretionary approach to flexibility was taken as regulators thought it would be better to deliver a safe but ineffective drug to patients than make them go without a treatment that turned out to be effective.
There was more pressure from patient activists in the US, and at the FDA, a patient representative took part as a voting member of the advisory committee meeting.

Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU

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