Op-Ed: Alzheimer’s Drug Approval a Big Leap Forward for FDA

This piece was originally published in RealClear Policy on January 20, 2023.

The Food and Drug Administration (FDA) may have had a slow 2022, but 2023 is already off with a bang. On January 6, agency regulators approved Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease. This landmark medication works by entering the brain and clearing amyloid plaques, which many researchers believe are responsible for the disease’s debilitating cognitive effects. The FDA approval not only gives millions of patients more time with their loved ones, but also helps restore agency credibility following its controversial Aduhelm (another Alzheimer’s drug) approval. Hopefully, the decision to green-light Leqembi is a bellwether for regulatory reform and renewed flexibility at the FDA. Only time will tell if America’s drug regulator grants patients greater access to life-saving drugs.

Alzheimer’s is an unrelenting disease that robs sufferers of all their memories and meaningful connections. The awful affliction claims more than 120,000 lives in the United States each year, and the burden posed by the disease is set to double by 2060. Treatment options are practically non-existent, and patients and their families are desperate for anything that can slow the disease’s toll. Fortunately, Leqembi appears to offer that brief respite from Alzheimer’s. As Nature senior reporter Sara Reardon notes, the sponsors’ phase III trial, “conducted in about 1,800 people with early-stage Alzheimer’s, found that the antibody slowed cognitive decline by 27% over 18 months of treatment.” However, patients will still need to weigh the cost and risks associated with the promising treatment. Three patients died over the course of clinical trials from complications related to brain bleeds and seizures. Even if patients think that’s worth the risk for a disease with a 100 percent mortality rate, they still may have to shell out a pretty penny for the drug. 

Leqembi is slated to cost $26,500 per year, and Medicare will keep coverage extremely limited for the foreseeable future. The Centers for Medicare & Medicaid Services (CMS) is leery of covering amyloid-lowering drugs after the controversial approval of Aduhelm, another anti-Alzheimer’s drug approved by the FDA. 

Read the full article here.