The US Food and Drug Administration (FDA) has approved the Alzheimer’s drug Leqembi. A study proves its effectiveness, the decline in memory and thinking ability is slowed down in patients in the early stages.
Alzheimer’s drug Leqembi has received full approval in the United States. The FDA said it could be used in patients with early-stage dementia and other symptoms caused by the neurodegenerative disease.
Leqembi, which is based on the active ingredient lecanemab, is considered the first drug that has been shown to slow down the progressive cognitive decline that triggers Alzheimer’s. So far, only Alzheimer’s symptoms – such as restlessness – could be treated with medication, but not the course of the disease.
Drug eliminates protein deposits in the brain
In January of this year, the Japanese pharmaceutical company Eisai, which developed Leqembi in cooperation with the US biotech company Biogen, received preliminary approval from the FDA. With full approval now, health insurance companies in the US can cover the cost of the very expensive drug. It is still unclear when the active ingredient will also be approved in Germany and Europe.
The basis for the approval was the first study results, according to which the drug effectively eliminates those protein deposits in the brains of those affected that are associated with Alzheimer’s. The FDA confirmed these results by reviewing data from a larger study of 1,800 subjects.
Leqembi is said to delay the progression of Alzheimer’s in the early stages of the disease by 27 percent.
scientist warn of side effects
This found that the drug slowed the decline in memory and thinking ability by around five months in those who were given it. This effect did not occur in those who had only received a placebo, i.e. a drug-free preparation. “This confirmatory study has demonstrated that it is a safe and effective treatment for patients with Alzheimer’s disease,” wrote FDA Neurology Drugs Director Teresa Buracchio.
Before the approval, scientists had warned of the sometimes serious side effects. In clinical tests, there had been occasional cases of brain swelling and bleeding. However, there had been no deaths.
With information from Claudia Sarre, ARD Studio Washington