The European Medicines Agency (EMA) has re-evaluated the anti-Alzheimer’s drug lecanemab and has decided to authorize the product. The decision comes after initially advising against it last July.
In a statement, the EMA indicates that it has “reexamined its opinion” and gives the green light to market lecanemab to treat “mild cognitive impairment” and “mild dementia” due to Alzheimer’s disease in its early stages.
In addition, the authorization specifies that it can be used in patients with “one or no copies of ApoE4, a certain variety of the gene associated with apolipoprotein E. For the population restricted to these characteristics, the benefits of lecanemab in slowing the progression of the Symptoms are greater than risks.
The refusal to allow the use of this drug in July, the Agency recalls, referred “to a broader group such as all Alzheimer’s disease patients.
“This is the news we were 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 a certain caution, because the EMA is a very conservative entity that thoroughly evaluates the risk situation of patients, who were here. as one of the key points to be able to accept the treatment,” as 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, we needed to know that all the research in this field would continue.”
The executive director of Alzheimer’s Research UK, Hilary Evans-Newton, also considers this partial authorization to be positive: “Although it is not a cure, lecanemab is an important step forward,” she also told the SMC. “This progress, however modest, represents a major advance in the way Alzheimer’s is treated.”
However, the drug will be “accessible through a controlled program to ensure that the medicine is used exclusively in the indicated patients,” the EMA clarified when announcing this re-evaluation.
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