EU REGULATORS UNDER FIRE AFTER REJECTING BREAKTHROUGH ALZHEIMER’S MEDICINE
The European Union’s drug regulator has come under fire for blocking a breakthrough Alzheimer’s drug that already has market approval in five other countries.
A European Medicines Agency (EMA) committee recommended on Friday that Leqembi, also known as lecanemab, be denied market authorisation in the EU despite the treatment reducing cognitive decline in Alzheimer’s patients by 27 per cent in a late-stage clinical trial.
The agency said concerns about the side effects of the medicine, including “swelling and potential bleedings in the brain”, outweighed the impact it has on slowing the progression of Alzheimer’s disease.
Bart De Strooper, professor of Alzheimer’s disease at University College London, said that the risk of side effects was overstated.
He told the BBC’s Today programme on Saturday that the majority of the drug’s negative side effects were observed only on brain scans, and that most patients recorded no symptoms.
‘Glass half empty approach’
When asked why the EMA had taken its decision, Mr De Strooper suggested it was down to European cultural attitudes.
“In Europe [they] always look to the half-glass empty and in the States, they’re much more fighting and going forward and trying to do something about the problem,” Mr De Strooper said.
“All the more dynamic countries in the world do something about this disease and Europe is more thinking about side effects than about the benefits so it’s really disappointing,” he added.
The Alzheimer’s Society, the UK’s leading dementia charity, also criticised the EMA’s decision.
Mark MacDonald, associate director of evidence, policy and influencing at the charity, said:
“We’re disappointed that lecanemab has not met the safety and effectiveness requirements to be licensed in Europe.
“While we fully respect the decision, we acknowledge it will be really difficult news for people in Europe who may have been eligible for this drug.”
The Alzheimer’s Society of Ireland also came out against the ruling. In a statement, it said: “This news is not what we had hoped for – particularly as Leqembi is already available in other jurisdictions including the United States, China, Hong Kong, South Korea and Japan.
“The clinical trial data under consideration was the same and we are disappointed that the outcomes are different. We will continue to monitor the situation closely.”
Leqembi was developed by drugmakers Eisai and Biogen. Eisai said it intended to ask the EMA committee to re-examine its decision in a bid to win market approval in the EU.
‘Disappointing decision’
Lynn Kramer, Eisai’s chief clinical officer, said the decision was “extremely disappointing”, and added that “there is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression”.
John Hardy, a neuroscience professor at University College London, told the Financial Times that he expected the EMA to reverse its decision, saying that the ruling “will be revisited as US clinicians and others gather and report real-world experience”.
The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is yet to make a call on whether Leqembi will receive market authorisation in Britain.
An MHRA spokesman said: “We are currently completing a rigorous assessment of the evidence supporting lecanemab in the treatment of Alzheimer’s disease. Further information will be communicated in due course.”