Alzheimer’s disease is a tragic illness that currently lacks a cure. However, there is a glimmer of hope with the recent FDA approval of a new drug developed by Lilly. This innovative medication offers a fresh approach to addressing Alzheimer’s, opening up new possibilities for patients and their loved ones. Let’s explore the details of this significant development and its implications for the future of Alzheimer’s treatment.
Eli Lilly & Co.’s Alzheimer’s drug has become the second medication approved in the US to slow the progression of this debilitating disease affecting 6 million Americans. This milestone is a major achievement for Lilly and its stakeholders, who have been eagerly anticipating the drug’s approval since it showed promising results in clinical trials over three years ago. Known as Kisunla, the medication faced various regulatory hurdles on the road to approval but is now set to compete with Eisai Co.’s Leqembi, which has been on the market in the US since early 2023.
Lilly’s stock closed down slightly following the news of the approval, while shares of Eisai partner Biogen Inc. also experienced a decline. The Alzheimer’s drug is priced at $32,000 for the first year of treatment, slightly higher than the annual cost of Leqembi for an average-sized individual. However, doctors have the option to discontinue the medication once brain plaques, the toxic material the drug targets, reach minimal levels, as demonstrated in many trial participants after a year.
This means that the overall out-of-pocket cost of the drug may be lower than other amyloid medications, according to Lilly. Both the Eisai and Lilly products are infusions designed to remove toxic amyloid from the brains of early-stage Alzheimer’s patients. While they only modestly slow the progression of the disease, they have been approved for a minority of patients with Alzheimer’s. Common side effects of these medications include brain swelling and bleeding, with Lilly’s drug requiring less frequent dosing every four weeks compared to every two weeks for Leqembi.
The convenience of less frequent dosing and the ability to discontinue treatment are significant advantages, as noted by Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation. Despite facing several delays in bringing Kisunla to market, Lilly persevered through regulatory challenges to secure FDA approval following a unanimous vote of support from external advisors in June.
Alzheimer’s has been a key focus area for Lilly, but the company’s GLP-1 medications for weight loss have garnered significant attention and sales growth. Analysts predict a substantial increase in sales of Alzheimer’s medications, with projections reaching $13 billion by 2030 from $250 million this year. This development has been welcomed by organizations like the Alzheimer’s Association, which has advocated for approval and broader insurance coverage of amyloid-reducing drugs.
The rollout of Leqembi by Eisai and Biogen has faced logistical hurdles, compensation uncertainties, and stringent safety testing requirements. Medicare recently began covering these treatments, but hospital neurology programs were not initially equipped to administer the necessary monitoring for the medications. the approval of new Alzheimer’s drugs represents a positive step forward in the fight against this devastating disease, offering hope to those impacted by its effects.