Wednesday, May 3, 2023

Is donanemab ready for prime time?

We've been writing about the promise of donanemab since 2021, although not so much lately.  Being a "mab," it's another monoclonal antibody that removes amyloid from the brain.  Like Aduhelm and Leqembi, it can cause "amyloid-related imaging abnormalities," or ARIA.  With ARIA come brain swelling and microhemorrhages - with occasional fatalities.  Nevertheless, these treatments are removing amyloid plaques from the brain and appear to be slowing the progress of Alzheimer's disease.  The jury is still out on their effectiveness, but signs are pointing in the right direction.

Today, Eli Lily announced completion of a major trial for donanemab showing that it may be the most effective of the "mabs" so far.  But again, there were two fatalities associated with the treatment and a third fatality that's not being blamed on it.  The trial lasted 18 months, and it involved 1,700 patients.  Eli Lily must get their results properly documented and submit them to the FDA.  They plan to apply to the FDA in June for approval of donanemab as a treatment for Alzheimer's disease.

When marketed, it will need a new proper name and a price tag.  Biogen is selling Leqembi for $26,500 per year, but Lilly has not announced either a price or a name for their new treatment.  We also don't know how long it will take the FDA to approve donanemab.

1 comment:

  1. Thanks for the update. I have MCI and my dr. recommended starting Leqembi. I am getting an MRI this week but have family issues I need to deal with first. My father is dying and my sister had a Neuro event and remains in rehab with a trach and feeding tube. I am an ICU nurse and need to be here for my family right now. I am sixty three and score well on my neuro exams. Do you know if I can put this off for maybe six months to a year without having it affect me neuro status? Thanks you your site.

    ReplyDelete

Welcome Kisunla

We reported previously that the FDA's advisory panel had recommended approval of the monoclonal antibody treatment donanemab.  This foll...