Indianapolis, Indiana – An advisory committee recommended the approval of an Alzheimer’s drug made by Eli Lilly, potentially paving the way for the FDA to greenlight another medication that has demonstrated its ability to slow the progression of the disease. While not a cure, the drug was revealed in a clinical trial to reduce cognitive and functional decline in individuals in the early stages of Alzheimer’s by 35 percent over an 18-month period.
The discussion among committee members largely revolved around the safety of the drug, known as donanemab, which functions by clearing amyloid beta plaque in the brain, a hallmark of Alzheimer’s. Concerns were raised regarding the occurrence of a condition called ARIA, which led to the deaths of three patients receiving the drug during the trial, in contrast to no deaths in the placebo group. Despite these issues, the FDA appeared cautiously optimistic about the drug’s safety profile, citing that the findings were in line with similar drugs targeting amyloid plaques.
Despite the advisory committee’s endorsement of donanemab’s efficacy and benefits outweighing risks for patients with mild cognitive impairment and mild dementia, the importance of proper education for healthcare providers and patients was highlighted. Not all patients may receive the same level of benefit from the drug based on the stage of their disease and genetic factors.
If granted approval, donanemab would become the third anti-amyloid drug to receive FDA approval since 2021, following Aduhelm and Leqembi. Eli Lilly expressed optimism regarding the drug’s potential benefits and its commitment to providing a new treatment option for patients in need. The urgency for additional Alzheimer’s treatments was underscored by the agency, given the significant number of Americans affected by the disease.
While Eli Lilly’s approach of discontinuing treatment once amyloid levels reach a certain point may offer a unique advantage, the drug’s potential success in the market remains uncertain, according to analysts. Challenges in marketing and potential competition from alternative treatments were cited as factors that could impact donanemab’s commercial viability.
The path to approval for donanemab has not been without obstacles, with changes in trial measurements and delayed FDA decisions presenting hurdles for Eli Lilly. Patient testimonials during the advisory committee meeting provided emotional insights into the impact of Alzheimer’s and the perceived benefits of the drug. Critics argued against approving donanemab, cautioning against potential risks and questioning the overall impact of anti-amyloid drugs on patients.
While the discussion on donanemab continues, experts emphasize the need for diverse approaches to treating Alzheimer’s disease to address its complex nature. Current treatments offer only modest benefits, highlighting the necessity for research and innovation to unlock new avenues for combating the debilitating disease.