FDA Makes a Big Move on Alzheimer's Treatment

In a move with big implications for Alzheimer's treatment, the FDA on Thursday gave full approval to the first drug shown to slow the disease's progression, though modestly, reports the Washington Post. The drug, called Leqembi and marketed by Eisai and Biogen, received conditional approval back in January. The decision to give it full approval is more than semantics—it paves the way to broader government coverage under Medicare and Medicaid, notes Roll Call. What's more, private insurers typically follow the government's lead on such decisions, notes the AP. Given that Leqembi costs $26,500 a year, the decision has the potential to make the drug accessible to far more people.

"Today's action is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease," said Teresa Buracchio of the FDA's Center for Drug Evaluation and Research. "This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease." Leqembi goes after the buildup of amyloid plaque in the brain that is linked to Alzheimer's disease, explains CNN. It's not a cure, but clinical trials suggested it slowed cognitive decline by 27% over 18 months, per Axios. Some big caveats: It is designed for those with early or mild forms of the disease. Also, three people died during an 18-month study, though it was unclear whether the drug itself played a role in their deaths.

Approval could lead to heavy demand for the drug, which STAT News points out could be overwhelming for health care professionals. "If we're going to have the better drugs, we need a better system, too," writes University of Pennsylvania medical professor Jason Karlawish in a separate STAT op-ed. Medications such as this require extensive monitoring of patients to keep them safe from risks such as brain hemorrhages and swelling. "There are several compelling technological solutions that can minimize misdiagnosis, reduce the time and effort of a workup, educate patients and families, and mitigate risks," but it will take time and effort to get them in place. His op-ed goes into the details. (More Alzheimer's disease stories.)