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Published Oct 5, 2022

A New Drug For A Relentless Brain Disease

Explore the groundbreaking yet controversial FDA approval of Relyvrio, a new ALS drug born from the tenacity of its founders Josh Cohen and Justin Klee, fueled by public advocacy and innovative fundraising, offering a glimmer of hope to those battling this relentless disease despite limited evidence.
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  • Approval Debate

    The FDA's approval of the ALS drug Relyvrio has sparked significant debate due to the limited evidence supporting its efficacy. explains that the drug was approved based on a single small study, which showed that patients lived slightly longer and functioned better, but left many questions unanswered 1. Typically, a second study confirming these results would be required for approval. However, the FDA reconvened its advisory committee after receiving thousands of messages from ALS patients and their families, ultimately leading to the drug's approval 1.

       

    Public Pressure

    Public advocacy played a crucial role in the FDA's decision to approve Relyvrio. notes that the initial advisory committee voted against approval, but the overwhelming response from the ALS community prompted the FDA to reconsider 1. Thousands of emails and comments highlighted the desperation of those affected by the disease, emphasizing the need for any potential treatment. This public pressure led to a second vote, where the committee approved the drug 1.

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