The FDA has approved a new drug for the treatment of early-stage Alzheimer’s disease even though clinical trial results showed modest cognitive benefits.
describes a patient with Alzheimer’s who died after taking lecanemab.Still, in anticipation of accelerated approval of lecanemab and the anti-amyloid drug donanemab, which the FDA has also fast-tracked, the Alzheimer's Association filed a formal request last month with the Centers for Medicare & Medicaid Services to provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments.
"The current CMS policy to severely limit access to these treatments eliminates people's options, is resulting in continued irreversible disease progression, and contributes to greater health inequities. That's not acceptable," Pike added.welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.
"The progress we’ve seen in not only this class of treatments, but also in the diversification of treatment types and targets over the past few years, is exciting and provides real hope to those impacted by this devastating disease," Carrillo said.
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