FDA Panel Endorses New Alzheimer’s Drug by Eli Lilly

Eli Lilly has a new drug, donanemab, for Alzheimer’s disease, and it has just received a unanimous vote of confidence from an FDA panel.

CNN reported that the monoclonal antibody drug was ruled safe and effective by the panel on Monday, June 10, bringing it one step closer to approval by the FDA. Donanemab is meant to be administered during the early stages of Alzheimer’s. According to the Alzheimer’s Association, one in three older Americans dies with Alzheimer’s or another type of dementia. It causes more deaths than prostate cancer and breast cancer combined.

Donanemab functions by assisting the body in eliminating amyloid plaque accumulations in the brain, which are a defining feature of Alzheimer’s disease. As people age, dangerous deposits called plaques may collect in the brain. The alterations in the brain that seem to accompany Alzheimer’s disease appear to be slowed down by plaque removal.

The Eli Lilly medication attaches itself to the amyloid plaques as it travels through the brain, drawing the immune system’s attention and assisting in the plaques’ clearance. Initial research shows that those who take the drug see a 37% lower risk of disease progression, compared to the control group that did not take the drug.

However, the drug did also have some adverse effects. Three people died while taking the drug after developing micro-hemorrhages, and patients had a slightly higher mortality rate than those who did not take the drug (2%, compared to 1.7% in the control group). The pharmaceutical giant claimed to the panel that this was “generally comparable” among all the groups in the trials, and these adverse effects were “infrequent.”

Overall, the panel voted “yes” unanimously to the questions of whether the data demonstrated the drug’s effectiveness for treating Alzheimer’s disease and whether its benefits outweighed the risks for the population enrolled in the clinical trials. The FDA will consider the committee’s recommendation as it decides whether to approve the drug.

FDA panels have been making headlines in recent weeks thanks to their approval, and rejection, of various drugs.

Last week, an FDA panel overwhelmingly voted in favor of approving an updated COVID-19 vaccine but rejected the use of MDMA (known by its street name ecstasy) for PTSD treatment.

An FDA advisory group rejected MDMA therapy, which was thought to be a potential treatment for post-traumatic stress disorder (PTSD). The committee highlighted concerns about the background studies about the usage of the controversial psychedelic drug in their decision.

According to NPR, the panel decided on Tuesday, June 4, and stated that the data on MDMA use was insufficient to support the drug’s effectiveness in treating PTSD. Furthermore, the FDA panel ruled 10-1 that the risks of the medication significantly exceed the benefits and decided in a 9-2 decision that talk therapy, when combined with the use of MDMA, is ineffective in treating PTSD.