FDA Panel Recommends Much Anticipated Eli Lily Alzheimer’s Medication, Donanemab, for FDA Approval
A Food and Drug Administration advisory panel on Monday (6/10/24) endorsed the experimental Alzheimer's drug donanemab, which studies showed slowed early stages of the disease. The FDA is not compelled to follow the recommendation of the advisory committee of outside experts, but it often does so.
The advisory committee unanimously agreed the studies showed that donanemab was effective at treating people with an early stage of Alzheimer's disease, a stage known as mild cognitive impairment. The panel also said the benefits of the drug outweighed potential risks for people with early stages of the disease.
Last July, a study published in the Journal of the American Medical Association reported Eli Lilly's Alzheimer's drug slowed decline by 35% compared with a placebo group based on a measure of daily activities such as driving, managing finances and talking about current events.
Like other drugs that target and clear amyloid from the brain, studies showed donanemab had side effects that included brain swelling and tiny bleeds that could be detected via MRI.
Reisa Sperling, a professor of neurology at Harvard Medical School, testified about the benefits and risks of the drug. She said it's crucial to inform doctors that they should monitor for potential side effects and for doctors to discuss with patients the risks and benefits of the drug.
She also said side effects are inherent with amyloid-clearing drugs, which appear to be the best-known way to slow Alzheimer's disease progression.
"We haven't yet hit the full home run," Sperling said. "But right now, it is critical to do whatever we can to have an impact to slow this terrible, inexorably progressive disease and allow older people to be able to enjoy this time with their families."
Michelle Papka, founder and president of the Cognitive and Research Center, a clinical trial site in Springfield, New Jersey, said donanemab is not a miracle cure. It does not stop cognitive decline," Papka said. "But it could be part of an effective cocktail,and we've got to start somewhere."
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
“We look forward to more treatment options, and novel therapies that target other aspects of the disease, including lifestyle and behavioral-based interventions,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead.
Information sources: Alzheimer's Association, USA Today
