The treatment received conditional approval in January, but received full approval following a review of data from a further 1,800 patient study that showed the drug slowed cognitive decline by 5 months.
Leqembi, a treatment developed by Japanese firm Eisai, had already secured conditional approval in January following clinical results that showed the drug was effective at clearing a sticky brain plaque associated with the disease.
The way is now cleared for the drug to be covered by Medicare and other insurance plans.
A majority of Americans get their health coverage through Medicare and among them some 60 million seniors.
Full approval was granted by the FDA following a review of data from another 1,800 patient study that showed the drug slowing cognitive decline by 5 months in those who had received the treatment compared with those who received a placebo.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” Teresa Buracchio, FDA’s neurology drug director, said in a statement.
The drug’s prescribing information will include serious warnings about potential side-effects of the treatment including brain swelling and bleeding.
Alzheimer’s patients and advocates have been closely watching the approval process of this drug after Medicare officials announced they wouldn’t cover Leqembi until it received the FDA’s full approval.
At a cost of roughly $26,500 (€24,200) for a year’s supply of the drug which is taken intravenously, there were concerns that the treatment would overwhelm the programme’s finances.
Private insurers had followed Medicare’s lead by refusing to cover the drug until it was approved by the FDA.
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