The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use is reviewing the marketing authorization application for Lecanemab, an Alzheimer’s disease drug shown to slow decline cognitive.
Lecanemab has been approved by regulatory authorities in the United States, United Kingdom and other countries. However, last July it failed to gain approval from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Alzheimer’s disease is the most common form of dementia and the third leading cause of death in Europe. The European Medicines Agency (EMA) told Euractiv that it is currently reviewing its initial decision following a request from the original applicant, the Eisai laboratory.
“Unfortunately, while the evaluation of a drug is ongoing, we cannot provide any comment on possible timelines or outcomes”the EMA told Euractiv. When the CHMP reaches an opinion, it will then be announced publicly, the agency said.
“Once the European Commission has made a decision on the marketing authorization application, the EMA will publish the CHMP assessment report explaining the CHMP’s reasoning which led to its decision”added the EMA.
“Making treatment available in the EU”
Japanese manufacturer Eisai, which developed the drug with its US partner Biogen, confirmed it had already requested a review of the CHMP opinion with the aim of making Lecanemab available in the EU.
“We remain committed to making a meaningful difference for people with early-stage Alzheimer’s disease and their loved ones. Eisai is committed to working with the CHMP and other relevant authorities with the aim of making the treatment available in the EU”explains Gary Hendler, regional president and CEO of Eisai EMEA, to Euractiv. However, he refused to comment on the details of these “closed meetings”.
Despite the CHMP’s decision, Gary Hendler remains confident about the drug.
“Eisai’s global Phase 3 Clarity AD clinical trial demonstrated that Lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results”he says. It also highlights that the need for new, innovative therapeutic options targeting an underlying cause of disease progression remains unmet.
Counterbalancing risks
According to the EMA, its Committee for Medicinal Products for Human Use considered that the observed effect of Lecanemab (sold under the brand name Leqembi) in delaying cognitive decline did not outweigh the risk of serious adverse effects associated with the medicine. The main side effect that worries the agency is the risk of swelling and hemorrhage in the brain.
Dr. David C. Weisman, a neurologist at Abington Neurological Associates who has also worked for Biogen and Eisai, said that with proper monitoring, it is possible to detect brain swelling early and prevent it from occurring. it does not become symptomatic.
The neurologist, who uses Lecanemab to treat his patients in the United States, says he does not understand the EMA’s decision, but understands what motivated it.
“Alzheimer’s disease is very stigmatized. It has been called senility for many years, and it is still the case today”he maintains.
An unspoken reason for rejecting the drug, he said, is money, as presumably many people would use these drugs inappropriately, generating a costly bill that someone would have to cover.
For Dr. David C. Weisman, the drug slows the progression of the disease and, although some people may decide not to use it, “it is completely unfair to make it a general limitation.”
“Anti-science and anti-health”
“You should have the autonomy and the ability to say: this medication is not for me because it poses too many risks for me. But you should also be able to say: you know what? This disease is terrible, I have seen it take its toll, and I will do everything I can to slow it down.”explains Dr. David C. Weisman.
According to him, during this review phase, Eisai could perhaps present the committee with pharmacoeconomic data, talk about its launch in the United States and alleviate the EMA’s fear that all Alzheimer’s patients receive this medicine.
“It’s hard to go from zero to one. And now we’re at one. We have established a sort of spearhead against this disease, and other innovations will emerge”he maintains. “The European Union doesn’t even accept reality, it’s totally unfair. It’s anti-science, anti-medicine and anti-health.”
Safe and effective
Following the approval of Lecanemab for the treatment of early-onset Alzheimer’s disease by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Paola Barbarino, chief executive of Alzheimer’s Disease International, said in a announced that the role of the EMA is crucial in ensuring that medicines sold in Europe are safe and effective.
But she added that many people with dementia want the choice to take a medication that can slow the progression of the disease.
“We now see a real risk of pushing wealthy Europeans to travel to the UK for treatment, leading to huge inequalities and a shift towards a society where access to medicines is dependent on income rather than needs »she laments.
The Alzheimer Europe organization was equally disappointed with the EMA’s negative opinion on Lecanemab.
“Instead of excluding all patients from this new treatment due to safety concerns, we would have hoped that the European Medicines Agency would authorize the medicine with a clear risk management plan to address potential side effects”reacted Jean Georges, executive director of Alzheimer Europe, in a press release.
