US health officials last Friday authorized a new drug for neurodegenerative Alzheimer’s disease with the goal of slowing cognitive decline in patients.
The new treatment, which will be marketed under the name Leqembi, is now recommended by the US Medicines Agency (FDA, its acronym in English) for patients who have not yet reached an advanced stage of the disease.
It is given intravenously once every two weeks, and is being developed by Japanese pharmacist Eisai, in partnership with North American Biogen.
The FDA said in a statement that this marks an “important step in the fight to effectively treat Alzheimer’s,” which affects an estimated 6.5 million Americans.
Leqembi, the active ingredient called lecanemab, targets deposits of a protein called beta-amyloid.
Although the exact cause of Alzheimer’s disease is still not well understood, patients’ brains contain amyloid plaques, which form around their neurons and eventually destroy them.
This is what causes the amnesia characteristic of the disease. In later stages, sufferers are unable to perform daily tasks or carry on conversations.
The FDA’s authorization is based on the results of clinical trials 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 full data “soon.”
These studies were conducted with nearly 1,800 people followed up for 18 months, and revealed a 27% reduction in cognitive decline in patients treated with likanimab. A novelty for a drug of this type.
But the study also revealed serious adverse effects: Some patients who were treated experienced bleeding in the brain. At least one person who received treatment has died.
“Given these concerns, whether lecanemab will truly be a game changer, as some say, remains to be seen,” the experts wrote in the scientific journal The Lancet in early December.
Leqembi will launch at US$26,500 (€24,850) per year, with the goal of “advancing 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 treatment the FDA has recently approved, following June 2021’s Aduhelm (which uses a molecule called aducanumab).
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