The US Food and Drug Administration (FDA) has fully approved a drug that slows the progression of Alzheimer’s disease for the first time.
The FDA has granted full regulatory approval to Leqembi – a drug by Japanese manufacturers Eisai and US drugmakers Biogen.
Up to now, other approved drugs targeted only the symptoms of the progressive disease, but Leqembi focuses on a protein in the brain, beta-amyloid, believed to be one of the main causes of Alzheimer’s.
The FDA’s decision came amid concerns about the drug’s price, safety and accessibility.
Leqembi will cost $26,000 (£20,000) a year, although Medicare – the US health insurance programme primarily for the elderly and disabled – is to largely foot the bill.
When researchers measured the drug’s effectiveness in a clinical trial, Leqembi slowed down the progression of the illness of those with mild cognitive impairment or early-stage disease by 27% over an 18-month period.
However, some medical professionals have criticised it for contributing to brain swelling and haemorrhages – there were also three deaths linked to the drug in the trials.
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Leqembi was approved for people with mild cognitive impairment or early-stage Alzheimer’s disease.
The drug is administered intravenously every two weeks and experts recommend patients get periodic brain scans to monitor for any side effects.
The Chicago-based Alzheimer’s Association praised the FDA’s decision.
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The treatment could “give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love”, Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.
Ms Pike added: “This gives people more months of recognizing their spouse, children and grandchildren.”
Some 6.7 million 65-year-olds and over suffer from Alzheimer’s in the US, while about 900,000 people are affected by the illness in the UK.
