Eli Lilly, a pharmaceutical company headquartered in Indianapolis, Indiana, received positive news when a panel of independent advisors to the Food and Drug Administration (FDA) recommended the approval of their experimental Alzheimer’s drug, donanemab. The recommendation paves the way for the treatment to receive full approval in the U.S. later this year, expanding treatment options for the more than 6 million Americans who have Alzheimer’s – the fifth-leading cause of death for adults over 65.
In a major vote, the committee unanimously agreed that the benefits of Eli Lilly’s donanemab outweigh its risks, with a focus on addressing the significant unmet medical need in Alzheimer’s treatment. The drug showed effectiveness in treating patients at the early stages of the disease, although more data is needed on its efficacy in diverse patient populations.
The road to approval for donanemab has not been without its challenges. Initial setbacks and last-minute reviews by the FDA underscore the agency’s cautious approach to evaluating treatments for Alzheimer’s, particularly after the controversial approval of Biogen and Eisai’s Aduhelm. Despite the hurdles, donanemab and Leqembi represent significant milestones in the long history of failed attempts to develop effective Alzheimer’s treatments.
Both donanemab and Leqembi are monoclonal antibodies targeting amyloid plaque in the brain to slow disease progression, although they are not cures. Safety concerns, such as brain swelling and bleeding, have been observed in patients taking these drugs, highlighting the need for careful monitoring and management of side effects.
Eli Lilly’s phase three trial demonstrated that donanemab has the potential to delay Alzheimer’s progression by 29% compared to a placebo, similar to the results seen with Leqembi. The debate over testing for tau as a requirement for accessing the drug adds another layer of complexity to its usage, with advisors leaning towards not making tau testing a prerequisite for treatment.
Overall, the positive recommendation for donanemab from the FDA advisory panel signifies a step forward in addressing the urgent needs of Alzheimer’s patients. As Eli Lilly looks ahead to bringing this treatment to market, continued vigilance and research will be essential to ensure the safety and efficacy of the drug for those in need.
