Independent FDA Advisory Panel Recommends Approving ALS Drug

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

Written byAmanda Heidt

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ALS attacks the nerve cells needed for walking and speaking.

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A panel of independent advisers to the US Food and Drug Administration voted Wednesday (September 7) to recommend the agency approve a novel therapy to treat amyotrophic lateral sclerosis, otherwise known as Lou Gehrig’s disease. The drug, called AMX0035, had previously been rejected by the same group earlier in the year, but new evidence presented by the company that developed it, Massachusetts-based Amylyx Pharmaceuticals, prompted a surprising reversal that also comes amid an aggressive lobbying campaign by ALS patients and their families.

“We applaud and thank the FDA advisory committee for their vote to support approval of AMX0035 and we urge the FDA to swiftly approve,” the ALS Association says in a statement shared with the media. “Americans living with ALS cannot wait. We are grateful for the support of thousands of members of the ALS community who have strongly advocated for approval of AMX0035.”

ALS, a debilitating neurodegenerative disease ...

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Meet the Author

Amanda Heidt
Amanda first began dabbling in scicom as a master’s student studying marine science at Moss Landing Marine Labs, where she edited the student blog and interned at a local NPR station. She enjoyed that process of demystifying science so much that after receiving her degree in 2019, she went straight into a second master’s program in science communication at the University of California, Santa Cruz. Formerly an intern at The Scientist, Amanda joined the team as a staff reporter and editor in 2021 and oversaw the publication’s internship program, assigned and edited the Foundations, Scientist to Watch, and Short Lit columns, and contributed original reporting across the publication. Amanda’s stories often focus on issues of equity and representation in academia, and she brings this same commitment to DEI to the Science Writers Association of the Rocky Mountains and to the board of the National Association of Science Writers, which she has served on since 2022. She is currently based in the outdoor playground that is Moab, Utah. Read more of her work at www.amandaheidt.com.
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