Alzheimer’s drug lecanemab, EMA re-examining marketing authorisation

The European Medicines Agency’s human medicines committee is re-examining the marketing authorisation application for the Alzheimer’s disease (AD) drug lecanemab, a treatment that has been shown to slow cognitive decline.

Lecanemab was approved by regulators in the US, the UK, and other countries. Still, it failed last July to get approval from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Alzheimer’s is the most common form of dementia - it’s Europe’s third leading cause of death. The EMA told Euractiv that it is currently reviewing its original decision following a request by the initial applicant, Eisai.

“Unfortunately, while the evaluation of a medicine is ongoing, we cannot provide any comment on possible timelines or outcomes,” the EMA told Euractiv. When the CHMP reaches an opinion, this will then be publicly announced, the EMA said.

“Once the European Commission has issued a decision on the request for marketing authorisation, EMA will publish the CHMP assessment report explaining the CHMP’s rationale supporting its opinion,” the EMA added.

‘We aim to make the treatment available in the EU’

Japanese drugmaker Eisai, which developed the drug with its US partner Biogen, confirmed that it has already sought re-examination of the CHMP opinion with the aim to make lecanemab available in the EU.

“We remain focused on making a meaningful difference to those living with early AD and those closest to them. Eisai is committed to working with the CHMP and other relevant authorities with the aim of making the treatment available in the EU,” Eisai EMEA Regional Chairman and CEO Gary Hendler told Euractiv. He declined to comment further on details of these “closed meetings”.

Despite the CHMP’s decision, Hendler remains confident about their drug.

“Eisai’s phase 3 global Clarity AD clinical trial demonstrated that lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results,” Hendler said. He highlighted that there remains a significant unmet need for new innovative treatment options that target an underlying cause of the disease’s progression.

Risk counterbalance

According to the EMA, its human medicines committee considered that the observed effect of lecanemab (sold under the brand name Leqembi) on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the medicine. The agency’s main side effect of concern was potential swelling and bleeding in the brain.

Dr. David C. Weisman, a neurologist with Abington Neurological Associates who also did work for Biogen and Eisai, said that with proper monitoring, one could catch the brain swelling early and prevent it from becoming symptomatic.

Weisman, who is using lecanemab to treat his patients in the US, says he doesn’t understand the EMA’s decision, but he believes he understands what motivated it.

“Alzheimer’s disease is very stigmatised. It’s been called senility for many years, and we’re still seeing that,” Weisman said.

Weisman also said an unspoken reason for the drug’s rejection is money since there may be an assumption that a wave of people will be using these drugs inappropriately, generating a costly bill that someone needs to cover.

Weisman said that the drug slows down the course of the disease, and while there could be individuals who decide not to use it, “to make this an overall limitation is just totally wrong”.

‘Anti-science and anti-health’

“You should have the autonomy and the ability to say: this drug is not for me because it has too much risk for me. But you should also be able to say: you know what? This disease is terrible, and I've seen it ravage people, and I will do anything I can to slow it down,” Weisman said.

Weisman said that during this re-examination phase, Eisai could perhaps show the committee pharmacoeconomic data, talk about its launch in the US, and to decrease the EMA’s fear that all Alzheimer’s patients would be getting this drug, Weisman said.

“It’s hard to go from zero to one. And now we’re at one. We've established like a beachhead on this disease, and further innovations are going to happen, but you have to accept that we're now at one,” Weisman said. “And the EU to not even accept reality is just totally wrong. That is anti-science, anti-medicine, and anti-health.”

Safe and effective

Following the approval of lecanemab in the treatment for early Alzheimer’s disease by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), Alzheimer’s Disease International CEO Paola Barbarino said in a statement that the EMA is crucial in ensuring that medicines sold within Europe are safe and effective.

However, she added that many people living with dementia want the choice to be able to take a medication which may slow the progress of the condition.

“We are now seeing a real risk driving wealthy Europeans abroad to the UK to seek treatment, leading to huge inequities and a move towards a society where access to medications depends on income rather than need,” Barbarino said.

The organisation Alzheimer Europe 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 authorise the medicine with a clear risk management plan to address potential side effects,” the Executive Director of Alzheimer Europe Jean Georges said in a statement.

[By Christoph Schwaiger | Edited by Brian Maguire | Euractiv’s Advocacy Lab ]

This article is part of our special report on Alzheimer’s Disease: detection, diagnosis, treatment.