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For Amylyx AMX0035 Panel Review, US FDA Relied Heavily on Temporary Voting Members

 
• By Sue Sutter

Peripheral and Central Nervous System Drugs Advisory Committee has held two of FDA’s most closely watched meetings in recent years, but there was little overlap between the panel that reviewed Amylyx’s ALS drug and the one that evaluated Biogen’s aducanumab 16 months earlier.

FDA advisory committee member puzzle
• Source: Alamy

Many comparisons have been drawn between the US Food and Drug Administration’s review of two high-profile, neurodegenerative disease drugs – Amylyx Pharmaceuticals, Inc.’s AMX0035 (sodium phenylbutyrate/taurursodiol) for amyotrophic lateral sclerosis and Biogen, Inc./Eisai Co., Ltd.’s Alzheimer’s treatment Aduhelm (aducanumab-avwa).

Both drugs target devastating diseases with high unmet need and few therapeutic options. Both came into their advisory committee meetings with efficacy data that could be viewed as problematic, but...

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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EU CHMP Opinions And MAA Updates

 
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