ALBRIOZA Commercial Launch
Amylyx Highlights
1st
RELYVRIO®Ⓡ and ALBRIOZATM
RELYVRIO (sodium phenylbutyrate
and taurursodiol) and ALBRIOZA
(sodium phenylbutyrate and
ursodoxicoltaurine) are the first drug
to show statistically significant
functional benefit and observed
survival benefit in ALS
Approved in the United States and Canada
Pending CHMP re-examination process in Europe following
negative CHMP Opinion in June 2023 - supported by robust
clinical data published in The New England Journal of Medicine
Jun.
2022
Sep.
2022
Fall
2023
Strong Global IP Position
Composition of matter patents
issued; NCE exclusivity received;
orphan drug exclusivity received
I+I
ALBRIOZA
approved for use
with conditions
RELYVRIO
approved
* Amylyx intends to seek re-examination of the negative CHMP opinion as announced on June 23, 2023.
Final CHMP
Opinion post
re-examination*
AMYLYX
3
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