Another New Potential Dementia Drug to Treat Alzheimer’s Disease
2023 is shaping up to be quite the year with the release of several new dementia drugs. As we have previously shared, pharmaceutical companies Biogen and Eisai received traditional approval by the FDA on July 6th for use of their drug Leqembi (generic name lecanemab). Through their completed Phase III drug trial, Leqembi has proven efficacy to slow the progression of Alzheimer's disease by 27%.
Another new dementia drug, donanameb, produced by pharmaceutical company Eli Lilly, is now hopeful to enter the treatment field after their Phase III trial results showed successfully slowing the progression of Alzheimer's disease by 35%. Eli Lilly is hopeful to receive traditional FDA approval of donanameb by the end of 2023, at which time the price will be determined for this drug (competition between Leqembi and donanameb may have an impact on price).
It is important to keep in mind that neither Lequembi or donanameb can improve symptoms; however, they are administered to slow and/or halt disease progression only in early stages of Alzheimer's disease.
Real world impact: In some trial participants with relatively minor cognitive impairment who started taking donanemab, cognitive decline slowed by as much as 60%. The drug was also proven to clear around 90% of the total amount of amyloid from the brain. Once individuals had minimal amyloid levels, the investigators switched them to a placebo. In the year after the switch, those who had taken donanemab continued to decline at a slower rate than those who had initially received a placebo.
While some experienced a 60% cognitive decline on the drug, the over all slowed disease progression determined was 35%... which translates to slowing the disease by 4.5 - 7.5 months according to Dawn Brooks, Eli Lilly's Global Development Leader.
How do Leqembi and Donanemab compare?
LEQEMBI (generic name lecanemab):
- Leqembi is designed to target forms of amyloid and also removes plaques
- Leqembi received FDA traditional approval for use on July 6, 2023
- Leqembi has been proven to slow decline on cognition and function by 27% for patients in the early stages of Alzheimer's disease
- Phase III trial tested close to 1,800 early stage patients with Alzheimer's disease for 18 months
- The most common side effects experienced include headache, infusion-related reactions, swelling and bleeding in the brain, and amyloid related imaging abnormalities (ARIA)
- Leqembi must be administered intravenously (by IV infusion) once every two weeks and has an annual cost of $26,500
- Medicare coverage of Leqembi is now available but for patients to receive they must be enrolled in a federal database to track safety and efficacy
DONANEMAB:
- Donanemab is designed to specifically target various forms of plaques
- Donanemab does not yet have FDA approval to administer the drug and is hopeful to receive by the end of 2023.
- Donanemanb has been proven to slow decline on cognition and function by 35% for patients in the early stages of Alzheimer's disease (there is no impact made on those with further progression of Alzheimer's disease)
- Phase III trial tested close to 1,736 early stage patients with Alzheimer's disease for 76 weeks
- 37% of patients in Phase III trial experienced brain swelling & bleeding, a higher rate than Leqembi. Amyloid related imaging abnormalities (ARIA) are a largely experienced side effect
- Donanemab must be administered intravenously (by IV infusion) once every month and the annual cost is still to be determined
- Medicare coverage of donanemab is not available until FDA traditional approval is received... granted enrollment & terms for receiving are still yet to be determined
We will continue to monitor the development and impact of both Leqembi and donanedab closely and provide updates as we learn more. There is no doubt that this is an exciting time for dementia research as these two new dementia drugs have provided a glimmer of hope for impact on Alzheimer's disease.
While we are encouraged by this forward progress starting to be made, we remain acutely aware of the many challenges and downsides still apparent, one being that these treatments are currently only proven to impact Alzheimer's disease... just one form out of hundreds of forms of dementia. That said we will keep our nose to the grindstone in continuing to fund research that will impact bringing viable treatments for all forms of dementia to market that are accessible and affordable to all.
