New hope for Alzheimer’s sufferers as FDA gives fast-track approval to experimental drug


An experimental Alzheimer’s disease drug that appears to slow down cognitive decline has been given fast-track approval by the US Food and Drug Administration.

The approval on Friday comes after clinical trial results published last November indicated that the drug, lecanemab, successfully slows cognitive decline in people with mild impairment from the disease.

The trials also showed that treatment with the drug, which will be sold as Leqembi, also carries a risk of brain swelling and bleeding.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr Billy Dunn, director of the FDA’s neuroscience division, in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

The FDA can give accelerated approval of a drug for serious conditions if it is expected to help patients more than products already available.

Leqembi is produced by Japanese pharmaceutical company Eisai and its US partner Biogen. The companies applied for accelerated approval last July.

Alzheimer’s disease is an irreversible brain disorder that destroys memory and thinking skills. It affects more than 6.5 million people in the US, according to the FDA.

Clinical trials found that cognitive decline was 27 per cent slower over 18 months in people who took lecanemab than those who did not, according to the study which was published in The New England Journal of Medicine.

A total of 1795 people between the ages of 50 and 90 years old with early Alzheimer’s disease took part in the study, with half receiving lecanemab and half not.