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# ALS Group Seeks Faster OK for Amylyx Experimental Drug
- URL: https://www.fdaweb.com/als-group-seeks-faster-ok-for-amylyx-experimental-drug/
- Published: 2021-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:54:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149108

The ALS Association (ALSA) says FDA should follow its guidance and emulate the urgency shown by Health Canada and the European Medicines Agency to work with Amylyx to move its AMX0035 treatment toward approval. The association [says](https://www.prnewswire.com/news-releases/als-association-calls-on-fda-to-follow-the-lead-of-canadian-and-european-counterparts-in-expediting-access-to-promising-new-treatment-301268788.html?ref=fdaweb.com) AMX0035 “is a clinically safe drug that slowed disease progression and increased survival. Americans living with ALS (amyotrophic lateral sclerosis) deserve the same access to AMX0035 that Canadians and Europeans are expected to receive.”

The ALSA statement says an FDA 12/2019 guidance permits the agency to rely on one adequate and well-controlled study under specified circumstances. It references an Amylyx 9/2020 publication of a Phase 2 trial that showed “that the treatment has a significant effect in slowing the progression of ALS. A follow-up publication demonstrated that the treatment also increases survival by at least six months.”

ALSA president **Calaneet Balas** says people with ALS have repeatedly told FDA they are willing to accept greater risk to have access to new drugs to treat the disease. She says that following interactions with Health Canada and European regulators, Amylyx has said it intends to submit for approval in those regions. U.S. patients may have to wait a year longer than patients in those jurisdictions to have access to AMX0035, she says.

“We look to FDA to continue to use available regulatory authorities, including those developed in partnership with our stakeholders, to move forward on AMX0035, as well as any other future developmental agents having similar findings, with urgency,” Balas wrote to FDA acting commissioner **Janet Woodcock**. “We also understand this pathway may require post-market study, but those should not delay access for people with ALS… \[F\]ast approval and aggressive oversight from the FDA have \[the\] realistic possibility to significantly extend the lifespan and reduce the functional decline of the tens of thousands of Americans we serve, precious productive and joyful months that ALS would otherwise take from them.”