For the first time, the U.S. Food and Drug Administration (FDA) has fully approved a drug that slows the progression of Alzheimer’s disease.
The FDA has granted full regulatory approval to the drug Leqembi, made by Japanese manufacturer Eisai and US drugmaker Biogen.
Other approved drugs so far only target 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 was motivated by concerns about the drug’s price, safety and accessibility.
Leqembi costs $26,000 (£20,000) a year, although health insurance – us Health insurance plans for seniors and people with disabilities – mostly pay bills.
Image: Associated Press
When researchers measured the drug’s effectiveness in clinical trials, Leqembi slowed disease progression by 27 percent in patients with mild cognitive impairment, or early-stage disease, over 18 months.
However, it has been criticized by some medical professionals for causing brain swelling and bleeding — and three deaths in trials have been linked to the drug.
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Leqembi is approved for patients with mild cognitive impairment or early Alzheimer’s disease.
The drug is administered intravenously every two weeks, and experts recommend that patients undergo regular brain scans to monitor for any side effects.
The Chicago-based Alzheimer’s Association praised the FDA’s decision.
Joanne Peck, president and CEO of the Alzheimer’s Association, said in a statement that the treatment could “give people in the early stages of Alzheimer’s disease more time to be independent and do the things they enjoy. “.
Ms Pike added: “It gives people more time to recognize their spouses, children and grandchildren.”
In the US, around 6.7 million people aged 65 and over have Alzheimer’s disease, while in the UK it affects around 900,000 people.