FDA Grants Final Approval to Alzheimer’s Drug Leqembi, but Questions Remain
The Food and Drug Administration (FDA) has officially granted final approval to the anti-Alzheimer’s drug Leqembi, developed by Eisai and BiogenBIIB, marking a significant milestone in the fight against this devastating disease. Leqembi, also known as lecanamab, has shown promising results in a formal phase 3 trial, demonstrating its ability to slow the progression of memory loss and cognitive impairment in patients with early-stage Alzheimer’s disease.
During the 18-month trial, Leqembi reduced the progression of Alzheimer’s symptoms by approximately 27 percent, providing hope for patients and their families. As a monoclonal antibody, the drug works by targeting and reducing the amount of amyloid beta, a material that accumulates in the brains of individuals with Alzheimer’s. While the presence of amyloid beta is associated with Alzheimer’s, scientists continue to debate its exact role in the disease.
However, it is crucial to note that Leqembi does not reverse existing brain damage caused by Alzheimer’s nor does it halt the disease’s progression entirely. Its primary function is to slow down the advancement of Alzheimer’s symptoms. It remains unclear if the benefits of Leqembi persist beyond the 18-month trial period, and there is currently no evidence supporting its efficacy in later-stage Alzheimer’s or other forms of dementia such as vascular dementia, frontal-temporal dementia, or Lewy-Body dementia.
To determine eligibility for Leqembi treatment, patients must receive a diagnosis of early-stage memory loss caused by Alzheimer’s disease and undergo screening to confirm the presence of amyloid beta buildup. This screening can be done through a PET scan or a spinal tap. Additionally, patients must be tested for a specific gene called APOE4, which may increase the risks associated with the drug. Regular MRI imaging is also required to monitor potential side effects, such as amyloid-related imaging abnormalities (ARIA), which can lead to brain swelling and, in rare cases, bleeding.
Despite its potential benefits, Leqembi does come with risks. Three participants in the trial experienced brain bleeds that were likely associated with the drug, resulting in their unfortunate deaths. While most cases of hemorrhages were minor, individuals taking blood thinners, those with two copies of the APOE4 gene, and individuals with cerebral amyloid angiopathy (CAA) may be at a higher risk.
Leqembi administration involves patients visiting a clinic, hospital, or doctor’s office every two weeks for approximately an hour-long infusion. The drug needs to be taken for as long as it continues to demonstrate clinical benefits. Initially, Leqembi will be administered primarily at academic medical centers and specialty clinics.
Regarding cost, the drugmakers have announced that Leqembi will be priced at around $26,500 per year. Medicare has agreed to cover the drug, but only for early-stage Alzheimer’s patients who are enrolled in a drug trial or whose doctors participate in a national registry that tracks patients’ progress while taking Leqembi. The Veterans Administration will cover eligible individuals aged 65 or older. Commercial insurance providers are likely to follow Medicare’s lead.
However, Medicare beneficiaries may still bear a significant portion of the cost. As Leqembi is classified as a Part B drug rather than a more common Part D drug, many Medicare patients will be responsible for 20 percent of the drug’s cost, which amounts to over $5,000 annually. Additionally, Medicare generally does not cover the initial PET scan required for eligibility, which can cost approximately $2,500. Some Medicare Supplement (Medigap) plans and Medicare Advantage (MA) plans may cover certain out-of-pocket expenses.
Looking ahead, the FDA is anticipated to approve other monoclonal antibodies within the next year. Similar to Leqembi, these drugs aim to eliminate the plaques in the brains of Alzheimer’s patients. Eli Lilly has submitted a request for FDA approval of a monoclonal antibody called donanemab. In the future, researchers hope to develop combination drugs that target both amyloid beta and another protein called tau, which may also play a role in Alzheimer’s development.
While Leqembi and similar drugs offer promise in temporarily slowing the progression of Alzheimer’s disease, they also present known risks. Based on current evidence, these drugs provide limited assistance to only a fraction of individuals living with dementia. It is crucial to gather as much information as possible and consult with trusted clinicians before making any decisions regarding treatment options.
Furthermore, the approval of Leqembi raises policy concerns. The Kaiser Family Foundation estimates that Medicare spending could increase by $9 billion annually due to Leqembi’s introduction, leading to higher premiums and increased taxes since general tax revenues fund two-thirds of Medicare Part B costs. Although Congress has granted limited authority to Medicare to negotiate drug prices directly with manufacturers, Leqembi will not be subject to this process for another 13 years. The long-term costs to the Medicare program will only become clear once more information is available about the drug’s benefits, risks, and its adoption rate among Alzheimer’s patients.
In conclusion, Leqembi and drugs of its kind hold promise in slowing the progression of Alzheimer’s disease, albeit with known risks. It is essential for individuals to educate themselves and engage in discussions with trusted healthcare professionals to make informed decisions about treatment options. The approval of Leqembi signifies progress in the field of Alzheimer’s research, but much more work is needed to find effective treatments for all individuals affected by this debilitating condition
