The recommendation paves the way for the treatment to receive full approval in the United States later this year.

If cleared for use, donanemab would become the second Alzheimer's drug of its kind to enter the U.S. market, following the approval of Leqembi, a treatment developed by Biogen and Eisai. This approval would provide expanded treatment options for the more than 6 million Americans of all ages who suffer from Alzheimer's, a disease that ranks as the fifth-leading cause of death for adults over 65.

During the advisory panel meeting on Monday, 11 committee members unanimously agreed that the available data on donanemab demonstrated its effectiveness in treating early-stage Alzheimer's patients. However, they also noted the need for more data on the drug's impact specifically in Black and Hispanic patients, as well as other demographic groups.

In a subsequent vote, the advisors unanimously agreed that the benefits of donanemab outweighed its risks. Panel member Sarah Dolan, a consultant for the non-profit organization Critical Path Institute, highlighted the significant medical need for effective Alzheimer's treatments.

This recommendation follows previous challenges faced by Eli Lilly in bringing the drug to market. In March, the FDA conducted a last-minute meeting with an advisory panel to further review the safety and efficacy of donanemab. Additionally, the agency rejected the drug in January 2020 due to insufficient data. However, donanemab and Leqembi represent significant milestones in Alzheimer's treatment after years of unsuccessful efforts to develop effective medications.

Both donanemab and Leqembi are monoclonal antibodies that target amyloid plaque in the brain, a prominent characteristic of Alzheimer's disease. They aim to slow the progression of the disease in patients at its early stages. However, it is important to note that neither treatment is a cure. Drugs targeting and clearing amyloid plaque can potentially cause brain swelling and bleeding, sometimes with severe or fatal consequences.

Eli Lilly's phase three trial, involving over 1,700 patients, showed that donanemab reduced the progression of Alzheimer's by 29% compared to a placebo after approximately 18 months. These results align with those seen with Leqembi. However, patients needed to test positive on a PET scan for amyloid plaque and tau, another protein associated with Alzheimer's severity, to be included in the trial.

One of the key discussions during the advisory panel meeting centered around the requirement of tau testing for eligibility. While Eli Lilly argued in favor of amyloid plaque testing but not tau testing, most advisors agreed that tau tests should not be mandatory. They believed that requiring tau testing would limit the population that could benefit from donanemab.

Notably, around 24% of trial participants experienced brain swelling, while 31% experienced brain bleeding. Most of these cases were mild to moderate, with only a small portion experiencing severe symptoms. The FDA expects the drug's label, if approved, to include a strong warning about the risks of brain swelling and bleeding, especially for those with two copies of the ApoE4 gene.

In conclusion, the recommendation from the FDA advisors for the approval of Eli Lilly's Alzheimer's drug donanemab is a significant step forward in tackling this devastating disease. The potential approval of donanemab and the availability of Leqembi offer hope for improving treatment options for millions of Americans living with Alzheimer's.