Europe is changing its assessment and giving limited approval to lecanemab, a controversial Alzheimer’s disease drug.
The European Medicines Agency (EMA) has re-evaluated the Alzheimer’s drug lecanemab and decided to authorize the product. The decision comes after an initial recommendation against it was made last July.
In its statement, the EMA said it had “reconsidered its opinion” and was greenlighting the marketing of lecanemab to treat “mild cognitive impairment” and “mild dementia” caused by early-stage Alzheimer’s disease.
Additionally, the approval states that it can be used in patients with “one or no copy of ApoE4, a specific variant of the apolipoprotein E-related gene. For a population limited by these characteristics, the benefits of lecanemab in slowing the progression of symptoms are greater than the risks.
The refusal to authorize the drug in July, the agency recalls, concerned “a broader group such as all patients with Alzheimer’s disease.
“This is the news we have been waiting for”
Neurologist and clinical director of the Alzheimer’s Center Ace in Barcelona, Merce Rovira, believes that “this is news that we have been waiting for with some caution, since the EMA is a very conservative organization that carefully evaluates the risk situation of the patients who were here as one of the key points allowing take treatment,” he told the Science Media Center (SMC).
Rovira adds: “Europe needed this news. “I needed to know that we had the ability to treat patients, we needed to know that all the research in this area would continue.”
Alzheimer’s Research UK chief executive Hilary Evans-Newton also sees the partial approval as positive: “Although it is not a cure, lecanemab is an important step forward,” she also told SMC. “This progress, modest as it may be, represents a major advance in the treatment of Alzheimer’s disease.”
However, the drug will be “available through a controlled program ensuring that the medicine is used exclusively in designated patients,” the EMA said in announcing the re-evaluation.