The first drug that slows Alzheimer's has finally received FDA approval

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

Leqembi received a preliminary approval in January that allowed it to be used in a limited capacity. That approval was conditioned on the two drug makers conducting a confirmatory study to verify the drug's clinical benefit.

Though Leqembi slows Alzihmer’s progression, it is not a cure. Instead, it addresses the underlying biology that spurs Alzheimer's advancement. The drug works by reducing amyloid plaques, or "misfolded" proteins that form in the brain of a person with Alzheimer's. 

Leqembi isn’t the only drug targeting beta-amyloid plaque buildup to treat Alzheimer's. Aduhelm received approval under the same accelerated pathway in 2021, but it’s still not fully FDA-approved. But what sets Leqembi apart from its predecessor is that the drug demonstrated actual clinical benefit in addition to simply reducing the buildup of the aforementioned proteins.

Besides needing a medical prescription, taking the drug will require professional administration in a hospital or infusion center every two weeks. The company, though it may not be its sole responsibility, recognizes its need to boost accessibility. In a public statement, Christopher Viehbacher, the CEO of Biogen, said the company’s main focus now is to work with Eisai to make Leqembi “accessible to eligible patients as soon as possible.”

The drug’s hefty price tag of $26,500 will unfortunately make it inaccessible to most. Current rules mean that it’s unlikely to be covered by Medicare. According to the Alzheimer's Association, those on Medicaid only should be able to get coverage of the FDA-approved drug in most cases. But, even if Medicaid does cover it, patients would be responsible for a 20 percent copay – or about $5,300. Experts predict the total cost of Leqembi treatment can run upward of $90,000 a year, if you take infusions and laboratory tests into account.

An expensive treatment program is something to consider for the one in nine Americans who are over the age of 65 that have Alzheimer’s dementia. That number is expected to grow as the nation’s aging population continues to grow. The number of Americans 65 and older is projected to climb from 58 million in 2021 to 88 million by 2050. This has led to an increased focus on treatments and diagnostics for Alzheimer’s, like blood tests that can detect the disease.

This article originally appeared on Engadget at https://www.engadget.com/the-first-drug-that-slows-alzheimers-has-finally-received-fda-approval-165058452.html?src=rss