The Biogen-developed treatment, called lecanemab, appears to have a more clear-cut effect on slowing the disease than the company’s previous Alzheimer’s drug, Aduhelm.
The Medicines and Healthcare products Regulatory Agency’s investigation comes after a study showed prenatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.
Clinicians and researchers teamed up to investigate how inappropriate proinflammatory mechanisms contribute to the pathogenesis of drug-refractory epilepsy.
The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.