Opinion: Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?

While the FDA may have made missteps with Aduhelm, denying approval for the #ALS treatment AMX0035 won't fix them. What it will do is keep people with ALS from accessing…

On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what might be the most effective treatment to date for amyotrophic lateral sclerosis. The panel’s decision is not binding, and the FDA could disregard its recommendation when it issues its final decision on the treatment, called AMX0035, in June.

For people like me who have been diagnosed with ALS, the rejection landed like a sucker punch. This devastating disease progressively robs people of their ability to move, speak, and eventually breathe. While the disease course varies, most with it die within five years. There are no effective treatments or cures.

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