Amylyx Will Submit ALS Drug For Approval In The Coming Months

Continues ‘As Fast As Possible’ Approach With AMX0035

 
• By Mandy Jackson
  
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After discussions with the US FDA, the company determined it can file AMX0035 based on Phase II/III results and interim Phase III data. Amylyx is sticking with its go-it-alone strategy for global commercialization.

Physiotherapist assisting a patient with Amyotrophic Lateral Sclerosis
AMX0035 slowed disease progression in CENTAUR as assessed by an ALS functional rating scale • Source: Alamy

Amylyx Pharmaceuticals, Inc. said on 15 September that it will submit a new drug application (NDA) to the US Food and Drug Administration “in the coming months” seeking approval for AMX0035 to treat amyotrophic lateral sclerosis (ALS), well before completion of its soon-to-be-initiated Phase III clinical trial. The FDA filing plan is a shift from just two months ago when the Cambridge, MA-based private company, which intends to commercialize its drug globally on its own, raised $135m to fund the Phase III study and file AMX0035 with Canadian and EU regulators.

Exactly when Amylyx could file in the US was unclear as recently as July, when the company announced its new...

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