Manufacturer Eli Lilly announced on Monday that a second drug, which moderately slows the progression of Alzheimer’s disease, could receive approval by the end of this year.
Lilly submitted an application for traditional approval to the Food and Drug Administration (FDA) last quarter and anticipates that the agency will make a decision by the end of the year.
According to Lilly, its monoclonal antibody named donanemab demonstrated a 35% reduction in Alzheimer’s disease progression compared to a placebo in an 18-month clinical trial with 1,700 early-stage patients. This roughly equates to a delay of about four months in disease progression.
The company reported even greater benefits for participants in the earliest stage of the disease, with a 60% reduction in decline compared to the placebo group.
Lilly presented these findings at the 2023 Alzheimer’s Association International Conference and concurrently published them in the Journal of the American Medical Association (JAMA).
If approved, donanemab would become the second successful Alzheimer’s drug on the market following the FDA’s recent approval of Biogen and Eisai’s Leqembi. Although neither drug is a cure, they could expand treatment options for those in the early stages of Alzheimer’s.
With over 6 million cases of Alzheimer’s in the United States, a number projected to increase with the aging population, approximately 1 million individuals in the early stages of the disease stand to benefit the most from this drug.
Both therapies are monoclonal antibodies that target amyloid, a brain plaque. Leqembi is administered via intravenous infusion every two weeks, while donanemab is administered every four weeks.
While both drugs significantly reduce plaque levels, questions remain regarding the clinical significance and overall degree of benefit.
An editorial in JAMA accompanying the trial results expressed concerns about racial disparities in treatment, particularly as minority groups are typically diagnosed in later stages of the disease.
Similar to the trial for Leqembi, the donanemab trial had limited representation from minority groups, with 96% of U.S.-based participants being white and 94% being non-Hispanic. Lilly noted that fewer Black or Hispanic individuals had positive scans confirming both amyloid and tau proteins, a requirement for study participation.
Consequently, it is challenging to assess the safety and efficacy of donanemab among American Indian or Alaska Native, Asian, Black, or Hispanic populations.
However, there are significant risks associated with donanemab, including three drug-related deaths among participants who experienced serious brain bleeding or swelling known as amyloid-related imaging abnormalities (ARIA). Donanemab exhibited an ARIA rate of 37%, compared to 15% for the placebo group.
In an editorial, Jennifer Manly of Columbia University Irving Medical Center and Kacie Deters of the University of California, Los Angeles, emphasized the need for clinicians, patients, and families to weigh the potential benefits of treatment (an average delay of four months in disease progression) against the financial and quality-of-life costs associated with infusions, MRI monitoring, and the risk of ARIA and brain volume loss.
Lilly did not disclose the pricing for donanemab if it receives approval, but Leqembi has an annual cost of $26,500.
The Centers for Medicare and Medicaid Services has stated that Medicare will cover Alzheimer’s drugs as long as they receive full FDA approval and companies collect data on real-world effectiveness.
Medicare patients may face thousands of dollars per year in co-insurance costs. Without supplemental coverage, enrollees are responsible for 20% of the cost after meeting a deductible.
In addition to the cost of the drug itself, patients may also be responsible for potentially tens of thousands of dollars in additional expenses. It is unclear if Medicare will cover the costs of medical visits or regular brain scans necessary for monitoring a patient’s progress.
Copyright 2023 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Denial of responsibility! VigourTimes is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
