Health Canada first to approve Amylyx' Albrioza for ALS

14 June 2022

Amylyx Pharmaceuticals’ (Nasdaq: AMLX) shares closed down 3.9% at $13.00 on Monday, despite announcing it has received the first regulatory approval for its Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), from Health Canada, for the treatment of amyotrophic lateral sclerosis (ALS).

Clinical data demonstrated a statistically-significant and clinically-meaningful benefit in functional outcomes for people with ALS taking Albrioza (also known as AMX0035) compared to people taking placebo, either as a stand-alone therapy or when added to existing treatments for ALS.

This decision marks the first marketing approval for Albrioza issued to Amylyx worldwide. A decision on the drug is expected from the US Food and Drug Administration in September.

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