Alzheimer’s disease is complex, and it is therefore unlikely that any one drug or other intervention will ever successfully treat it in all people living with the disease. Still, in recent years, scientists have made tremendous progress in better understanding Alzheimer’s and related dementias and in developing and testing new treatments.
Patients with Alzheimer’s disease have a build-up of a particular protein, amyloid-beta, in their brains. This leads to the degeneration of neurons. There are a number of drugs being tested in large-scale clinical trials that selectively target these amyloid-beta plaques called monoclonal antibodies.
On January 6, 2023, the Food and Drug Administration (FDA) approved the monoclonal antibody Leqembi, also through its Accelerated Approval pathway. A study showed that lecanemab slowed cognitive decline in people with early-stage Alzheimer’s disease but at the risk of adverse side effects. The drug was fully approved on July 6, 2023.
On July 2, 2024, the FDA approved Eli Lilly’s Alzheimer’s drug donanemab, marketed as Kisunla, an amyloid-targeting therapy intended to treat patients with early symptomatic Alzheimer’s, including those with mild cognitive impairment and those exhibiting mild dementia stages of the disease with confirmed amyloid pathology.
Read more about Leqembi and donanemab below and watch a recording of the PMC Community Discussion on Anti-Amyloid Treatments for Alzheimer’s Disease:
Leqembi (lecanemab)
According to a research study published on November 29, 2022, the experimental drug lecanemab was found to slow cognitive decline in people with early-stage Alzheimer’s disease but at the risk of adverse side effects.
In a study of 1,800 participants, lecanemab slowed cognitive decline by 27% compared with a placebo. Participants receiving the drug were more likely to experience brain bleeding and swelling than those receiving the placebo.
“The benefit is real; so too are the risks,” said PMC Co-Director Dr. Jason Karlawish.
Leqembi was approved by the FDA on January 6, 2023 using its Accelerated Approval Pathway program. This program allows the FDA to approve drugs that could be “potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.”
On July 6, 2023, the FDA fully approved the drug.
Read more about lecanemab:
- There’s finally a fully approved Alzheimer’s drug – but getting it won’t be easy, TIME
- Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage will likely follow, NPR
- FDA grants accelerated approval for Alzheimer’s disease treatment FDA.gov
- FDA gives green light to Leqembi, aka lecanemab Alzforum
- Dr. Karlawish answers common questions about Leqembi SciLine
- Dr. Karlawish warns of lecanemab safety concerns Science
- Alzheimer’s drug shows modest success slowing declines in memory, thinking, NPR
- The science behind lecanemab, BioArtic AB
Donanemab
The Penn Memory Center and Penn Medicine are working to make Kisunla (donanemab) available to patients. Details will be announced at those plans develop.
On July 2, 2024, the FDA approved Eli Lilly’s Alzheimer’s drug donanemab, marketed as Kisunla, offering another option for adults with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment (MCI) and mild dementia stages.
“The FDA approval of donanemab is another great step forward in Alzheimer’s disease treatment,” Penn Memory Center Co-Directors Jason Karlawish, MD and David Wolk, MD wrote in a statement. “The Penn Memory Center clinicians are excited about the drug’s precision-medicine approach to achieve a target reduction in beta-amyloid. This is an exciting advance.”
Kisunla is now the second Alzheimer’s drug of its kind approved, following Leqembi. Both drugs are monoclonal antibodies that target toxic amyloid plaques to slow the disease’s progression in early-stage patients.