US health officials today authorized a new drug for the neurodegenerative disease Alzheimer’s aimed at slowing cognitive decline in patients.
The new treatment, which will be marketed under the name of Leqembi, is now recommended by the American Medicines Agency (FDA, its acronym in English) for patients who have not yet reached an advanced stage of the disease.
Administered intravenously once every two weeks, it is developed by the Japanese pharmaceutical Eisai, in partnership with the North American Biogen.
This represents “an important step in the battle to effectively treat Alzheimer’s disease,” which affects an estimated 6.5 million Americans, the FDA said in a statement.
Leqembi, whose active ingredient is called lecanemab, targets deposits of a protein called beta-amyloid.
Although the exact cause of Alzheimer’s disease remains poorly understood, patients’ brains harbor amyloid plaques, which form around their neurons and eventually destroy them.
This is what causes the memory loss characteristic of the disease. In later stages, sufferers are unable to carry out daily tasks or carry on conversations.
The FDA clearance is based on clinical trial results that showed the drug helped reduce amyloid plaques.
The agency also mentions the results of larger clinical trials, recently published in a scientific journal and for which the FDA expects to receive complete data “shortly.”
Conducted on nearly 1,800 people followed for 18 months, these studies revealed a 27% reduction in cognitive decline in patients treated with lecanemab. A novelty for a drug of this type.
But the study also revealed serious adverse effects: some of the patients treated suffered from brain hemorrhages. At least one person who received the treatment died.
“Given these concerns, whether lecanemab will truly be a game-changer, as some say, remains to be seen,” experts wrote in The Lancet in early December.
Leqembi will be launched at a price of US$26,500 (24,850 euros) per year, with the aim of “promoting patient access, reducing the global financial burden and supporting the sustainability of the healthcare system”, Eisai announced today in a statement. .
This is the second Alzheimer’s disease treatment recently approved by the FDA, after Aduhelm in June 2021 (which uses a molecule called aducanumab).
