FDA has required an additional MRI between the 2nd and 3rd Leqembi infusions to help detect amyloid-related imaging abnormalities with edema, or ARIA-E, earlier in treatment. The agency said ARIA-E is often asymptomatic but can also involve serious and life-threatening events, including seizures, status epilepticus, and deaths.
The previous monitoring schedule already included MRIs before the 5th, 7th, and 14th infusions, but FDA said its deeper review of the safety issue supported earlier imaging as well. The agency also said Leqembi was approved in 2023 for Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage disease.
For pharmacovigilance teams, this is a strong example of how postmarketing safety oversight can lead to practical risk-minimization changes without changing a product’s basic place in therapy. Monitoring language in labeling is not just a technical footnote; it is one of the clearest ways safety review changes how a medicine is used in real practice. That final point is an inference from FDA’s updated monitoring requirement
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