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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