A participant died in a clinical trial of a Federal Drug Administration-approved antibody treatment for Alzheimer’s disease, and the death may be linked to the drug, a new case report reveals.
The case, published in May in the Journal of Alzheimer’s Disease, details unreported adverse outcomes associated with the use of Lecanemab (Lequembi), an anti-amyloid plaque therapy intended to slow disease progression.
Despite receiving accelerated approval from the FDA in January, the drug faced a setback when the Center for Medicaid Services rejected a petition for broader coverage under Medicaid just a month later, maintaining a restrictive policy for this class of Alzheimer’s treatment. CMS’ analysis, which differs from FDA criteria, highlights lingering concerns regarding the drug’s safety and effectiveness, as outlined in their rejection letter….