Josh Cohen (L) and Justin Klee (Amylyx)

Once held back, Amy­lyx ex­ecs say the FDA is now push­ing for an NDA on ALS drug

It turns out the FDA is will­ing to take a look at Amy­lyx Phar­ma­ceu­ti­cals’ ALS drug af­ter all.

Rough­ly five months af­ter the FDA said it asked for a Phase III study to con­firm last year’s pos­i­tive Phase II re­sults, the agency has ap­par­ent­ly re­versed course. Amy­lyx will be sub­mit­ting its ALS drug for US ap­proval af­ter meet­ing with reg­u­la­tors last month, the com­pa­ny an­nounced Wednes­day.

The move comes on the heels of the FDA’s con­tro­ver­sial de­ci­sion to ap­prove Bio­gen’s new Alzheimer’s drug in June, one po­ten­tial­ly sig­ni­fy­ing of­fi­cials’ grow­ing will­ing­ness in rare neu­ro­log­i­cal dis­eases to get med­i­cines to pa­tients more quick­ly. Amy­lyx had pre­vi­ous­ly sub­mit­ted its ap­proval ap­pli­ca­tion in Cana­da, with fur­ther plans to do so in the EU by the end of the year, but the FDA re­mained a no­table hold­out.

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