The US Food and Drug Administration could decide this week whether to grant accelerated approval to the experimental Alzheimer's drug lecanemab, according to Eisai and Biogen, the companies that make the drug.
Lecanemab – one of the first experimental dementia drugs to appear to slow the progression of cognitive decline – has shown “potential” as an Alzheimer’s disease treatment, according to Phase 3 trial results, but raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.
, which can become life threatening. Some people who get may not have symptoms, but it can occasionally lead to hospitalization or lasting impairment. And the frequency of appeared to be higher in people who had a gene called APOE4, which can increase the risk of Alzheimer’s disease and other dementias.
“were numerically less common” among APOE4 noncarriers. The trial results also showed that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group. Even if the FDA offers accelerated approval of the drug, it will still be studied in more robust trials. And if those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval.
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