European drug regulators reject Leqembi's approval in European markets
Citing the risk of adverse events as being greater than any possible benefit from these immunotherapies.
In another case of European regulators going against America’s otherwise reckless drug approval process The European Medicines Agency has recommended a refusal to approve the Alzheimer’s immunotherapy Leqembi in Europe.
The recommendation came a few days ago and served as a hit to the already struggling Japanese company Eisai who partnered with Biogen in the development of the drug, as the uptake of this therapy has lagged behind expectations in recent months.
In citing the recommendation to refuse approval the EMA argued that the benefits of reducing Alzheimer’s progression appeared small, with benefits not outweighing the risk of developing adverse events such as brain bleeding and brain swelling known as ARIA (emphasis mine):
Although patients given Leqembi had lower CDR-SB scores than those given placebo, the difference between the two groups was small. EMA’s human medicines committee, the CHMP, considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the medicine.
The most important safety concern with Leqembi is the frequent occurrence of amyloid-related imaging abnormalities (ARIA), a side effect, seen in brain imaging, that involves swelling and potential bleedings in the brain. Although most cases of ARIA in the main study were not serious and did not involve symptoms, some patients had serious events, including large bleeds in the brain which required hospitalisation. The seriousness of this side effect should be considered in the context of the small effect seen with the medicine.
[…]
Overall, the CHMP considered that the benefits of treatment are not large enough to outweigh the risks associated with Leqembi. Therefore, it recommended refusing marketing authorisation in the EU.
As I have previously covered the world of Alzheimer’s immunotherapy has been hit with constant controversies, including the fact that many of these immunotherapies appear to have been approved with questionable clinical data and concerning adverse events.
It also doesn’t help that the most cited paper in Alzheimer’s pathology has been retracted due to allegations of fraud, putting the entire field under scrutiny regarding the actual role of amyloid in disease progression and raising concerns regarding the billions of dollars in research put towards pursuing the amyloid hypothesis.
In some ways this refusal to approve could help to slow down the rush to approve drugs with questionable efficacy, and possibly bring more attention regarding the actual utility of these drugs.
That being said, this refusal to approve does not mean that Leqembi will not see approval at some point in the future as Eisai can seek out re-examination within 15 days of the ESA’s decision.
Regardless, it’s important to point out the juxtaposition between two regulator’s approval processes. That is, why did Leqembi see fast-tracked approval here in the US under the guise that any treatment is better than no treatment, with many people downplaying the side effects as narratives to remove providing people hope while Euorpean regulators see small benefits with Leqembi that don’t outweigh the adverse events?
Why are cases of ARIA seen as acceptable in here yet unacceptable abroad? Why is there inconsistency in how the clinical trials are being perceived even though people are looking at the same trials and results?
In the end, there are many reasons why medications see approval, and rarely is it about the actual clinical benefit…
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Wow!! Sheepeoly Americans can be guinea pigs. I see I am mixing species.
"Leqembi", eh?
Marketing department, late evening:
"Joe, have you come up with a name for this new Alzheimer drug yet?"
- "No, and I need to go now, promised my daughter we'd test our new home cinema installation, but I'll come up with _something_ right after! Even if I'm tired."
"What you gonna watch?"
- "Lion King".