FDA Sets Up Adcomm To Review Amylyx's ALS Drug Next Month

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The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Amylyx Pharmaceuticals Inc's AMLX marketing application for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol) on March 30

  • AMX0035 is an investigational therapy to treat amyotrophic lateral sclerosis (ALS). 
  • The Company applied in December last year, and the FDA has granted Priority Review and assigned a Prescription Drug User Fee Act date for AMX0035 of June 29, 2022.
  • The submission to the FDA was based on CENTAUR Phase 2 trial data in 137 people with ALS. Based on a functional rating scale, which Amylyx used to measure its primary endpoint, AMX0035 showed a statistically significant reduction in disease progression over about six months.
  • A survival analysis conducted in all randomized participants who were followed for up to three years, AMX0035, demonstrated a 44% lower risk of death than those who started on placebo during the placebo-controlled phase. 
  • Median survival duration through the open-label long-term follow-up phase was 25.0 months in the group that started on AMX0035 and 18.5 months in the group that began on placebo, a 6.5-month difference.
  • Price Action: AMLX shares are down 0.46% at $21.72 during the market session on the last check Thursday.
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