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US FDA’s ALS Science Strategy Includes Near-Term Rare Neurodegenerative Disease Task Force

 
• By Ramsey Baghdadi

Five-year plan includes multi-phased approach to ALS at the same time that Amylyx’s AMX0035 is pending review with a late September decision deadline; action plan’s mid-term priorities for FY 2023-2024 include a cell and gene therapies safety project.

Neurodegenerative disease
The FDA's plan is aimed at accelerating product development for the treatment of rare neurodegenerative diseases. • Source: Shutterstock

The US Food and Drug Administration will establish a rare neurodegenerative diseases task force this year as part of its commitments under the Accelerating Access to Critical Therapies for ALS Act to develop and carry out an ALS/rare neurological disease action plan. The five-year action plan was announced 23 June.

The task force is one of two near-term items slated for fiscal year 2022; the other is establishing the public-private partnership for rare neurodegenerative diseases called for in the...

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