Replies to post #509443 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

I have been doing a little research into that. Here is what I found in relation to Kinsula.

This from the meeting highlights of the meeting that rejected the initial application:

Negative opinion for one medicine
The committee recommended not granting a marketing authorisation for Kisunla (donanemab), a medicine intended for the treatment of early Alzheimer’s disease. The committee considered that the benefits of this medicine were not large enough to outweigh the risk of potentially fatal events due to amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain.

For more information on this negative opinion, see the question-and-answer document in the grid below.

More information: https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kisunla-donanemab_en.pdf