FDA Gives Full Approval to Alzheimer's Drug

Facts

• On Thursday, the US Food and Drug Administration (FDA) gave full approval to Biogen and Eisai's Alzheimer's drug Leqembi, the first medication shown in clinical trials to slow the progression of the disease.¹
• The drug — which received accelerated approval from the FDA in January — clears brain plaque associated with Alzheimer's. A confirmatory study of 1.8K patients showed that it slowed cognitive decline by around five months, with the agency calling it "safe and effective."²
• The Centers for Medicare and Medicaid Services stated that they would grant coverage for the drug, which costs about $26.5K a year, on the day it receives full FDA approval, extending coverage to upwards of a million potential Medicare patients.³
• The FDA has directed doctors to prescribe Leqembi to patients with mild dementia or mild cognitive impairment, a pre-Alzheimer's condition, instructing doctors to test patients' brains for the presence of the toxic amyloid protein — an indicator of the disease. The FDA added its strictest black-box warning against potential brain swelling and bleeding.⁴
• Medicare coverage is contingent on doctors participating in a patient registry to track drug efficacy and side effects, a move that the Alzheimer's Association has criticized as a barrier to access. Meanwhile, some Alzheimer's experts have questioned whether the slow in cognitive decline is enough to be noticeable.⁴
• Eisai's chairman and CEO of US operations has estimated that in the first three years, 100K patients would receive the treatment. About 1.5M Americans are estimated to be in the early stages of Alzheimer's, while another 5M have progressed too far to be eligible for the drug.⁴

Sources: ¹CNN, ²Al Jazeera, ³NPR Online News, and ⁴New York Times.

Narratives

• Pro-establishment narrative, as provided by U.S. Food and Drug Administration. Leqembi has shown itself to be a safe and effective treatment for Alzheimer's, with the turnaround from accelerated to traditional approval being a testament to the responsiveness of the FDA. Millions of Americans now have hope to slow the progression of this frightening illness, and patients can rest assured that they are getting cutting-edge treatment that has been thoroughly tested and proven to be safe.
• Establishment-critical narrative, as provided by USA Today. The FDA has been proven to be a compromised organization when it comes to the approval of Alzheimer's medication, as they sweep an earlier controversy under the rug. Leqembi co-maker Biogen was found to be inappropriately involved in the FDA approval process for their drug Aduhelm, rushing a medication that was overly expensive with unclear efficacy. There is good reason to be skeptical of this latest drug in light of this history.