New Alzheimer’s drug approved in the USA
For the second time since 2021, a new Alzheimer’s drug is approved in the USA – an important advance for the treatment of dementia. But the euphoria is limited, because the approval study points to serious side effects such as brain bleeding.
The U.S. Food and Drug Administration (FDA) has approved a novel drug for the treatment of Alzheimer’s disease. The drug, to be marketed as Leqembi, represents „important progress toward effective Alzheimer’s treatment,“ the FDA said. The drug is recommended by the FDA for use in patients in whom the neurodegenerative disease is at an early stage.
In its statement, the agency pointed to preliminary data from a study published in September that showed Leqembi slowed cognitive decline in Alzheimer’s patients by 27 percent over an 18-month period. However, the same study had also pointed to serious side effects.
Some of the treated patients suffered brain hemorrhages. In addition, at least one person who received the treatment died. In its approval, the FDA included a warning about possible bleeding in the drug information.
Leqembi, whose active ingredient is called lecanemab, targets deposits of a protein called beta-amyloid. The cause of Alzheimer’s disease is not yet fully understood. What is certain, however, is that amyloid deposits form around neurons in patients‘ brains, destroying them over time. This process causes the memory loss characteristic of Alzheimer’s disease. The FDA’s approval of Leqembi is based on the results of clinical studies showing that the drug reduces amyloid deposits.
Not the first Alzheimer’s drug
Leqembi is the second Alzheimer’s drug to receive FDA approval since 2021. In June 2021, the agency had given the green light to Aduhelm, which is based on an active ingredient called aducanumab.
Following Aduhelm’s approval, there was considerable controversy over evidence of its efficacy. As a result of the approval, three high-ranking FDA representatives resigned; in addition, the agency later restricted its use. An investigative report by the U.S. Congress had also criticized the enormously high price of $56,000 per year for Aduhelm.
Aduhelm, like Leqembi, was approved by the FDA under an expedited procedure. This allows the drug agency to fast-track drugs for serious conditions without already approved treatments.
Alzheimer’s disease is the most common form of dementia. The brain disease causes loss of mental functions such as thinking, language, judgment and orientation, as well as death or severe damage to brain cells, especially in the cerebral cortex. The ability to socialize is also lost.