Last week, Eli Lilly and Company announced that it has applied for U.S Food and Drug Administration (FDA) approval for its Alzheimer’s treatment, donanemab, and expects an FDA decision by the end of 2023.

The data, released by Lilly, shows that donanemab reduced cognitive decline by 35% as compared to those taking a placebo in the 18-month Phase Three Clinical Trial involving more than 1,700 individuals in the early stage of Alzheimer’s disease who had a confirmed presence of amyloid plaque.

Like Leqembi® (lecanemab – irmb), that the FDA approved earlier this month, donanemab is a monoclonal antibody that targets beta amyloid plaques in the brain.   In addition, the Lilly study looked at another protein called tau that science believes has a role in the damage to the brain caused by Alzheimer’s.  The presence of tau may indicate more advanced disease. Study participants were divided by tau levels in their brain.  Those in the study with intermediate levels of tau and Mild Cognitive Impairment (MCI) slowed to 46% while those already progressed to early Alzheimer’s slowed to 36%.  Intermediate tau patients who were younger than 75 slowed by 45% percent, while older patients slowed by only 29%.

“This is an exciting time for Alzheimer’s disease research and offers new hope for families impacted by this life changing disease,” said Ken Zaentz, Alzheimer’s New Jersey President and CEO.  “The FDA approval of Leqembi® and the positive results from the donanemab trial are a testament to the power of scientific research and the importance of clinical trial participation to the drug discovery process.  In addition, while these drugs are not a cure and not the treatment for everyone with Alzheimer’s they further emphasize how vital it is to seek an early diagnosis when someone is experiencing cognitive issues.”

Donanemab is administered as an intravenous infusion once every four weeks. Patients need to have regular brain scans to monitor for possible side-effects, including brain swelling and bleeding. These usually resolve on their own over time but can be fatal in rare cases.

The Center for Medicare and Medicaid Services (CMS) has said that Medicare will cover Alzheimer’s drugs that may slow the progression of Alzheimer’s disease if full FDA approval has been received.  In addition, the drugs must be administered in an appropriate setting that participates in a registry to collect data to track safety and how the drugs work in a clinical setting.

For additional information, please contact the Alzheimer’s New Jersey Helpline at 888-280-6055 or visit www.alznj.org.