The European Medicines Agency (EMA) has reassessed the anti-Alzheimer’s drug lecanemab and decided to authorize the product. This decision comes after initially recommending against this measure last July.
In a press release, the EMA indicates that it has “reexamined its opinion” and gives the green light to the marketing of lecanemab to treat “mild cognitive impairment” and “mild dementia” due to Alzheimer’s disease in its early stages.
Furthermore, the authorization specifies that it can be used in patients presenting “one or no copy of ApoE4, a certain variety of the gene associated with apolipoprotein E. For the population restricted to these characteristics, the benefits of lecanemab to slow the progression of symptoms outweighs the risks.
The refusal to authorize the use of this drug in July, recalls the Agency, referred “to a broader group such as all patients suffering from Alzheimer’s disease”.
“This is the news we’ve been waiting for”
The neurologist and clinical director of the Ace Alzheimer Center in Barcelona, Mercè Rovira, believes that “this is the news that we were waiting for with some caution, because the EMA is a very conservative entity that carefully evaluates the risk situation of patients, which were here as one of the key points to be able to accept the treatment,” he told the Science Media Center (SMC).
Rovira adds that “Europe needed this news. “I needed to know that we had the possibility of treating patients, I needed to know that all research in this area would continue. »
The executive director of Alzheimer’s Research UK, Hilary Evans-Newton, also considers this partial authorization as positive: “Even if it is not a cure, lecanemab is an important step forward,” she said. -she also declared to the SMC. “These advances, however modest, represent a major advance in the way Alzheimer’s disease is treated.”
However, the medicine will be “accessible via a controlled program to ensure that the medicine is used exclusively in indicated patients,” the EMA said in announcing this re-evaluation.
