Is the risk of delaying patient access to a desperately needed potential treatment greater than the risk of facilitating access to an ineffective but relatively safe product? How important is regulatory precedence? And how much should patients influence the final outcome?
Key Takeaways
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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for treating amyotrophic lateral sclerosis was refused approval in the EU but was approved in the US before it was withdrawn following poor Phase III study results.
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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
These are some of the issues that the US Food and Drug Administration took into consideration when it decided whether to apply regulatory flexibility and finally approve Amylyx Pharmaceuticals, Inc
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