The US Food and Drug Administration has given full approval to the first drug that slows Alzheimer’s disease.
Trials of Leqembi concluded that it slowed cognitive decline by 27 per cent over 18 months.
The drug, also known as lecanemab, went to Britain’s regulators for approval in May. Experts have said it could be available in the UK as soon as next year.The drug has been described as potentially “the beginning of the end” for the disease. It was developed by pharmaceutical companies Eisai in Tokyo and Biogen in the US.
Leqembi is administered once every two weeks by intravenous infusion and is for early-stage patients with mild impairment.
Teresa Buracchio, acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said: “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
The FDA said it would require a warning on labels about possible brain swelling and bleeding. In trials 21 per cent of patients suffered brain swelling or bleeding, while only nine per cent of those who received the placebo did.
There was also a warning about the drug being given to patients already taking blood thinners.
The drug is an antibody treatment that is injected into the brain and works by reducing amyloid beta, a protein that builds into plaques and causes brain cells to die, as well as brain shrinkage.
The FDA’s decision was welcomed by patient groups.
Joanne Pike, Alzheimer’s Association president, said: “This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love.
“This gives people more months of recognising their spouse, children and grandchildren.” (Telegraph)