Replies to post #396907 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

ApoE e4 Carrier Status and Risk of ARIA

In Study 1, 6% (10/161) of patients in the LEQEMBI group were apolipoprotein E e4 (ApoE e4) homozygotes, 24% (39/161) were heterozygotes, and 70% (112/161) were noncarriers. The incidence of ARIA was higher in ApoE e4 homozygotes than in heterozygotes and noncarriers among patients treated with LEQEMBI. Of the 5 patients treated with LEQEMBI who had symptomatic ARIA (see Incidence of ARIA), 4 were ApoE e4 homozygotes, 2 of whom experienced severe symptoms. In addition, an increased incidence of symptomatic and overall ARIA in ApoE e4 homozygotes compared to heterozygotes and noncarriers in patients taking LEQEMBI has been reported in other studies. The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers [see Dosage and Administration (2.3)]. Consider testing for ApoE e4 status to inform the risk of developing ARIA when deciding to initiate treatment with LEQEMBI.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s000lbl.pdf

Good luck and GOD bless,