The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) is currently reviewing the application for marketing authorization for the Alzheimer’s drug Lecanemab. This medication has been shown to slow cognitive decline.
Lecanemab has been approved by regulatory authorities in the US, UK and other countries. However, approval for the drug failed in the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last July.
Alzheimer’s is the most common form of dementia and is the third leading cause of death in Europe. The medicines agency told Euractiv that it is currently reviewing its original decision at the request of first applicant Eisai.
“Unfortunately, we cannot comment on potential timelines or outcomes during the ongoing evaluation of a drug,” the drug agency said. If the Committee for Medicinal Products for Human Use comes to an opinion, this will be announced publicly, it said.
“Once the European Commission has taken a decision on the application for marketing authorization, the European Medicines Agency will publish the evaluation report of the Committee for Medicinal Products for Human Use, in which it explains the reasons for its opinion,” the European Medicines Agency added.
“We want to make the treatment available in the EU”
Japanese drugmaker Eisai, which developed the drug with its US partner Biogen, confirmed that it had already requested a reconsideration of the opinion of the Committee for Medicinal Products for Human Use. This is intended to make lecanemab available in the EU.
“We remain focused on making a meaningful difference for people living with early Alzheimer’s disease and their families. Eisai is committed to working with the Committee for Medicinal Products for Human Use and other relevant authorities to make the treatment available in the EU,” Gary Hendler, EMEA regional chairman and managing director of Eisai, told Euractiv. He declined to comment further on the details of these “closed sessions.”
Despite the committee’s decision, Hendler remains confident about her drug.
“Eisai’s global Phase 3 Clarity AD trial demonstrated that lecanemab met the primary endpoint and all key secondary endpoints with statistically significant results,” said Hendler. He emphasized that there remains a significant unmet need for new innovative treatments that target the underlying cause of disease progression.
Risk balancing
According to the European Medicines Agency The Committee for Medicinal Products for Human Use considered that the observed effect of lecanemab (sold under the brand name Leqembi) on delaying cognitive decline did not outweigh the risk of serious adverse side effects associated with the drug. The main side effect that concerned the agency was possible swelling and bleeding 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, brain swelling can be detected early and prevented from becoming symptomatic.
Weisman, who uses lecanemab to treat his patients in the U.S., said he doesn’t understand the European Medicines Agency’s decision but believes he knows what motivated it.
“Alzheimer’s disease is highly stigmatized. For many years it was referred to as senility and that is still the case today,” Weisman said.
Weisman also explained that an unspoken reason for rejecting the drug was money. One might expect a wave of people to use these medications inappropriately, creating a costly bill for someone to pay.
Weisman said the drug slows the progression of the disease. Although there may be people who choose not to take it, “making this a general restriction is completely wrong.”
“Anti-science and anti-health”
“You should have the autonomy and the ability to say, ‘This drug isn’t for me because it’s too risky for me.’ But you should also be able to say, ‘You know what? This disease is terrible and I have seen how it devastates people and I will do everything I can to slow it down,'” Weisman said.
Weisman said that at this stage of reconsideration, Eisai may present pharmacoeconomic data to the committee and talk about launching it in the U.S. to allay the drug agency’s fears that all Alzheimer’s patients would receive this drug.
“It’s hard to go from zero to one. And now we’re at one. We have established a beachhead against this disease and there will be further innovations, but you have to accept that we are at one now,” explained Weisman. “And the fact that the EU doesn’t even accept reality is just completely wrong. This is anti-science, anti-medical and anti-health.”
Safe and effective
Following the approval of lecanemab for the treatment of early Alzheimer’s disease by the UK Medicines Agency (MHRA), Paola Barbarino, chief executive of Alzheimer’s Disease International, said in a statement opinionthat the European Medicines Agency plays a crucial role in ensuring that medicines sold in Europe are safe and effective.
However, she added that many people with dementia wanted the choice of taking a medication that could slow the progression of the disease.
“We now see a real risk of wealthy Europeans traveling to the UK for treatment. This leads to huge inequalities and a move towards a society in which access to medicines depends on income rather than need,” said Barbarino.
The Alzheimer Europe organization was also disappointed by the Medicines Agency’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 approve the drug with a clear risk management plan to address potential side effects,” Alzheimer Europe chief executive Jean Georges said in a statement opinion.
[Bearbeitet von Brian Maguire | Euractiv’s Advocacy Lab]