medicine
Jul 17, 2023 | 10:53am
In the fight against Alzheimer’s disease, experts are excited about new weapons.
A drug called donanemab, developed by Eli Lilly, has successfully completed clinical trials and is expected to receive FDA approval in the fall.
People who took donanemab had a 40% lower risk of progressing from mild cognitive impairment to mild dementia or mild to moderate dementia.
If approved, donanemab would be the third Alzheimer’s drug to hit the market in recent months, following Rekembi and Adhelm.
This is “just the beginning of a new era in molecular therapy for Alzheimer’s disease,” says Dr. Gil Rabinovich, director of the UCSF Center for Alzheimer’s Disease Research. Wrote an editorial in JAMA magazine.
“This will be a very important and meaningful drug,” said Dr. Danielle Skovronski, Lilly’s chief scientific and medical officer. As quoted by Fierce Biotech.
“[T]This is a huge opportunity for patients,” added Skovronski.
Like Lekembi and Aduhelm, donanemab is a monoclonal antibody that attacks plaques in the brain made up of a protein called amyloid.
Amyloid plaques trigger the spread of another protein called tau. Both amyloid and tau proteins contribute to the development of Alzheimer’s disease.
The donamab trial also found that the drug slowed cognitive decline by 35% compared to placebo in people with low to moderate tau protein levels in the brain.
In fact, donanemab has been shown to be even better than Aduhelm and Rekembi in clearing amyloid plaques.
Also, while lekembi is intended to be taken for a long period of time, people taking donanemab can have a fixed-duration dosing schedule, meaning that patients may take or discontinue it in some cases. can.
“Many patients expect to be able to stop treatment as early as 12 months,” Skowronski said.
“It’s a big difference from being prescribed a drug that you might have to take for the rest of your life. And I think that’s exciting and important for the patient.”
Despite the excitement, experts say these new Alzheimer’s drugs have limitations and risks.
Donamab and other new drugs have been associated with swelling and bleeding in the brain. Three participants in clinical trials of donanemab died from these side effects.
People with the APOE4 gene have an increased risk of brain swelling and bleeding, which is associated with an increased risk of Alzheimer’s disease.
Furthermore, people with more advanced cases of Alzheimer’s disease showed little benefit compared to those who took placebo.
Donemab administration may therefore be limited to people with low to moderate levels of tau protein who present with mild disease.
Nevertheless, Skovronski and other medical experts are optimistic that FDA approval will come soon.
“Every day, there are patients who go through the early stages of Alzheimer’s disease, progress further, and stop benefiting from treatment.” In an interview with CNBC, Skovronski said:. “It’s a very imminent sense of danger.”
