Eli Lilly’s Alzheimer’s Drug Faces Unexpected FDA Review, Delaying Approval
In a surprising turn of events, Eli Lilly announced on Friday that the U.S. Food and Drug Administration (FDA) will subject its proposed Alzheimer’s drug, donanemab, to additional review. This unexpected move will result in a delay in regulatory action on the medication, which was widely anticipated to be approved this month.
The FDA has decided to hold an advisory committee meeting to thoroughly scrutinize the safety and effectiveness of donanemab. This drug is specifically designed to target amyloid beta, a sticky substance found in the brain that has been linked to the debilitating Alzheimer’s disease affecting approximately 6 million Americans.
The call for additional scrutiny has caught Lilly executives off guard, as it is uncommon for such a review to occur after the FDA has already provided an anticipated decision date. Despite this setback, Lilly remains confident in donanemab’s potential to provide significant benefits to individuals with early symptomatic Alzheimer’s disease.
Anne White, an executive vice president at Lilly, expressed this confidence, stating, “We are confident in donanemab’s potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease.” Lilly also highlighted that the FDA had conducted similar reviews for the two amyloid-targeting drugs it had previously approved, namely Aduhelm and Leqembi.
The approval of Aduhelm and Leqembi, both manufactured by Biogen and Eisai, drew significant attention due to adverse events such as brain bleeding, particularly among patients taking blood thinners. In fact, Aduhelm faced commercial challenges after Medicare declined broad reimbursement for the drug. Biogen and Eisai are currently seeking approval for a less-invasive method of administering Leqembi, aiming to make it more convenient for patients.
While clinical trials have shown that donanemab can slow cognitive decline in individuals in the early stages of Alzheimer’s, the use of amyloid-targeting drugs remains a divisive topic within the medical field. Marwan Sabbagh, a behavioral neurologist at the Barrow Neurological Institute, who served on the advisory committee for Leqembi, explained that these drugs do not reverse the effects of the disease. Instead, they slow down the rate of decline, making patients “less worse.”
Matthew Schrag, a neurologist at Vanderbilt University Medical Center, remains skeptical about the focus on amyloid as a treatment for Alzheimer’s. He believes that the benefits derived from these drugs are minimal, stating, “The absolute magnitude of the benefit is very small. We’ve got drugs that are getting a lot of attention that are probably going to leave a lot of patients disappointed.”
Donanemab is administered once a month through an infusion, and only certain medical centers have the capability to perform the procedure. Due to logistical constraints, Lilly expects that the initial launch of the drug will reach a limited number of patients and only contribute modestly to its earnings once approved.
Following the announcement, Lilly’s stock price experienced a slight decrease of less than 1 percent during premarket trading on Friday. The Alzheimer’s Association issued a statement in response, emphasizing the importance of safety and appropriate administration of treatments. They urged the FDA to swiftly move forward with the next stage of its review process on behalf of all those who could potentially benefit from donanemab.
As this story continues to develop, further updates will be provided.
