David Rosen Comments on FDA’s Regulatory Flexibility for ALS Drug

Foley & Lardner LLP Partner David Rosen is quoted in the Pink Sheet article, “What Confirmatory Evidence’ Does US FDA Need When Sponsors Want to Rely on a Single Trial?”, discussing the U.S. Food and Drug Administration’s (FDA) approval of Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis drug (ALS) Relyvrio.

Rosen said, “If they demonstrated that this does have a significant impact on survival, that’s not a bad metric to be supportive of approval,” however he questions the impact the FDA’s regulatory flexibility and decision-making for Amylyx’s ALS drug might have on future approvals.

“Is this setting the standards for the dataset that will be useful in other approvals… for serious, debilitating and life-threatening diseases where there are no other treatment alternatives, or is it going to try to spill over into other disease states? My prediction is that it’s not likely to do so, but that’s not going to stop companies from trying to push the envelope,” he added.

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