Amylyx Will Submit ALS Drug For Approval In The Coming Months
Continues ‘As Fast As Possible’ Approach With AMX0035
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.
You may also be interested in...
Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.
Biogen/Eisai’s aducanumab, as the first disease-modifying therapy and setting a precedent for accelerated approval, lifted the entire Alzheimer’s field.
The company, which has reported no R&D successes outside of its CGRP inhibitor platform, said verdiperstat did not differentiate from placebo on any endpoints in multiple system atrophy.