;Resize=(1200,627)&impolicy=perceptual&quality=mediumHigh&hash=30cdc6f844aae29b49a3be33c1c94eef18f15b5d2ec57133ba4ea793a7243e1b "New Alzheimer’s drug approved in the USA – you need to know that")
The Alzheimer’s drug Leqembi (active ingredient lecanemab) has now received full approval in the USA. The US Food and Drug Administration (FDA) announced on Thursday that it can be used in patients with early-stage dementia and other symptoms caused by the neurodegenerative disease. We clarify the most important questions.
1. Who developed the drug?
The Japanese pharmaceutical company Eisai developed Leqembi in cooperation with the US biotech company Biogen.
2. How exactly does Leqembi/ Lecanemab work?
Leqembi/Lecanemab contains monoclonal antibodies that target amyloid beta protofibrils. These threadlike, misfolded proteins are thought to be the early precursors to the larger amyloid plaques. These are the deposits in the brain that are associated with the destruction of nerve cells. These in turn are considered typical in Alzheimer’s patients.
3. Can the drug cure Alzheimer’s?
No, Leqembi cannot cure Alzheimer’s or stop its progression either. The aim is to delay the cognitive decline in patients in the early stages of Alzheimer’s. According to the phase III study, this was 27 percent after 18 months.
Nevertheless, the remedy is celebrated as a breakthrough. Leqembi is considered the first approved Alzheimer’s drug that targets the disease (the plaques) directly. So far, there are only drugs that stimulate brain performance or treat side effects of the disease, such as restlessness or depression.
4. Which patients is Leqembi/Lecanemab aimed at?
It is only suitable for Alzheimer’s patients in the early stages who have so far had only minor losses in their mental performance.
5. How did the drug perform in studies?
The manufacturers had already received preliminary approval from the FDA in January. The basis for this was the first study results, according to which the drug effectively eliminates those protein deposits in the brain of those affected that are associated with Alzheimer’s.
The FDA confirmed these results by evaluating data from a large study with 1800 subjects. 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. “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.
6. Does Lecanemab/Leqembi have any side effects?
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.
Deaths also occurred over the course of the 18-month study – 0.7 percent in the lecanemab group and 0.8 percent in the placebo group. The investigators therefore assumed that these were not related to the drug.
7. Can people in Germany buy Lecanemab/Leqembi or have a doctor prescribe it?
No. The active ingredient is currently only available in the USA. The cost is around $26,500 per year. FDA approval allows health insurance companies to cover the costs.
8. What are the chances of approval in Europe?
The manufacturers have already submitted an application for approval to the European Medicines Agency (EMA). A decision could be made later this year. Then the drug would also be available in Germany.