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Amylyx’s ALS Pledge Vs. FDA’s Obscure Withdrawal Authority: Which Holds More Power?

 
• By Sue Sutter

Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.

Horses in barn
Pulling a drug off the market may be more challenging that getting the horses back in the barn. • Source: Shutterstock

The second advisory committee review of Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis drug shined a light on the US Food and Drug Administration’s little-used authority to withdraw a drug’s approval for lack of substantial evidence of effectiveness.

It also could set a new standard in challenging new drug reviews – sponsors publicly committing to withdraw a drug when a definitive

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