Lecanemab, a first-of-its-kind, twice-a-month dementia jab, will get the go-ahead from the U.S. Food and Drug Administration, despite experts warning that it can trigger deadly bleeds in the brain.
Now a world-renowned dementia expert, and former FDA advisor who asked to remain anonymous, said he feared the decision could sway health chiefs in the United Kingdom to do the same.
He warned that approval of Lecanemab will ‘cost lives, not just in the U.S., but in the U.K. and other countries.
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The drug is a twice-a-month injection and was hailed as ‘the beginning of the end for Alzheimer’s when early trial results unveiled in September showed it could slow the disease by a third.
Since then, safety concerns have emerged, leading many experts to say it should not be approved until more is known.
The drug works by attacking a toxic protein in the brain called amyloid. Amyloid proteins circulate freely in the blood, but when they clump together in the brain and form plaques, it causes brain damage that triggers dementia symptoms.
Experts believe the chemical reaction in the brain when the Lecanemab removes the plaque can inflame blood vessels, raising the risk of bleeds.
The Mail on Sunday revealed that one in ten people who take the drug suffer life-threatening brain swelling, and one in six develop brain bleeds, according to data published by EISAI and Biogen, the drug manufacturers.
The MoS last month reported the case of one 79-year-old Florida woman who died suddenly after taking three doses of Lecanemab as part of a medical trial. Experts investigating her death concluded the cause was a lethal seizure triggered by the drug.
Despite this, Lecanemab is expected to be approved by American health chiefs next month.
‘There is so much pressure on the authorities to deliver this drug, I don’t think there’s any way they cannot approve Lecanemab,’ the former FDA adviser said. ‘It is almost certain it will get the green light in June.’
The calls have been led by the leading U.S. dementia charity, the Alzheimer’s Association, which has been accused of conflicts of interest and bias, which it denies.
It was reported last year that it received more than £220,000 from drug firm Biogen, which helped to develop Lecanemab.
A spokesman for the Alzheimer’s Association said: ‘We make decisions based on science and the needs of our constituents. ‘No contribution from any organization impacts the Alzheimer’s Association’s decision-making.’
The FDA has already fast-tracked the drug through the official approval process due to the pressing need for effective dementia drugs. It has also published guidance for prescribing the medication, so doctors can offer the injections as soon as it gets the green light.
All three patients who died of possible Lecanemab side effects in the trial had cerebral amyloid angiopathy, a build-up of amyloid plaque on the blood vessel walls that increases the risk of dangerous bleeding.
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Studies suggest that about half of all Alzheimer’s patients have cerebral amyloid angiopathy. There may also be a risk for those taking certain types of antidepressants, which are commonly prescribed to people with Alzheimer’s, experts claim.
It was initially believed that patients on blood thinner drugs, given to those suffering from heart disease, were at the highest risk of brain bleeds. But scientists at Vanderbilt University in Nashville, Tennessee, suggest that far more patients are at risk.
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‘Blood-thinners and some antidepressants could raise the risk of brain bleeds, but what worries me the most is that patients not on any of these drugs can also experience life-threatening side effects,’ says Robert Howard, professor of old age psychiatry at University College London’s Institute of Mental Health.
‘Once the FDA approves Lecanemab, it will be up to the UK medical regulators to make their call. I trust that they will make the right decision.’
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