“Unsafe”… The European Medicines Company refuses to launch a drug that slows the event of Alzheimer’s

Revealed on: 07/27/2024 (Final Up to date: 07/27/2024 at: 11:29)

Bethlehem – Ma’an – The European Medicines Company selected Friday to refuse to launch a drug for Alzheimer’s illness within the European Union that goals to gradual the cognitive decline of sufferers, as a result of it believed that this extremely anticipated drug is harmful.

The regulatory physique thought-about that the outcomes obtained by the drug known as “Leqembi” and permitted in the US “are disproportionate to the chance of hostile results related to it,” specifically “the likelihood bleeding within the mind of sufferers. “

Consultants predicted that numerous sufferers can be “troublesome” with this concept, which is often adopted by the European Fee, which has the ultimate choice.

The Japanese pharmaceutical firm “Eisai”, which created “Likembe” in collaboration with the American “Biogen”, confirmed that it’s going to submit a request for a “reconsideration of the opinion” of the European Medicines Company , expressing “deep disappointment.”

An announcement quoted Eisai’s medical director, Lynn Kramer, as saying, “There’s a vital unmet want for brand new and progressive therapy choices that concentrate on the underlying reason for illness improvement.”

In Might 2023, the US Meals and Drug Administration permitted the drug “Lequimbi”, of which lecanemab is part, for sufferers who haven’t reached a sophisticated stage of the illness. Eisai identified that additionally it is offered in Japan and China.

For many years, researchers have didn’t make vital progress in combating Alzheimer’s illness, which impacts tens of hundreds of thousands of individuals worldwide.

Round eight million individuals within the European Union endure from some type of dementia, and Alzheimer’s illness represents greater than half of those instances, in accordance with the Alzheimer’s Europe web site. As of now, there isn’t a treatment obtainable.

Medication has not but achieved a complete understanding of the true reason for Alzheimer’s illness, however mind scans of sufferers present that there are amyloid plaques that type round nerve cells and destroy them in the long term.

This results in reminiscence loss, that is the obvious manifestation of the illness. In its remaining phases, sufferers are not in a position to carry out duties and actions of day by day residing or have interaction in conversations.

The drug “Likembe”, which is taken as soon as each two weeks, reduces the variety of amyloid plaques, in accordance with what medical trials have proven.

However the EMA’s unfavorable opinion famous “specifically the frequent look in medical imaging of amyloid-related abnormalities (…) together with swelling and potential bleeding in mind of sufferers. “

Professor Tara Spiers-Jones, a neurodegeneration specialist on the College of Edinburgh, mentioned that this opinion by the European Medicines Company “can be a disappointment to many.”

However she mentioned in an announcement that “there are causes to be optimistic,” since lecanimab has proven that it’s potential to gradual the development of the illness she mentioned, “We should now make our efforts to seek out medicines new and safer to seek out. “

As for Bart De Strooper, a professor at UCL College Hospital in London, he mentioned that the European Medicines Company’s choice is “unlucky, however not sudden.”

He believed that “this outcome reveals the nice cultural distinction in the way in which by which dangers and innovation are considered in numerous sectors,” noting that “the Division Europe tends to see the cup as half empty, whereas international locations comparable to the US, China and Japan are watching. it because the half-full.”

The US Meals and Drug Administration gave the inexperienced mild in early July final 12 months to launch one other new drug for Alzheimer’s illness, developed by the American firm Eli Lilly, which is anticipated to gradual the development of the illness. illness

Selections about medicine in opposition to Alzheimer’s illness have been intently watched because the controversy over Aduhelm, which was permitted in June 2021 and was additionally developed by Eisai and Biogen and which additionally targets amyloid plaques.

“Adohelm” was the primary drug permitted in the US in opposition to the illness in 2003.

Nevertheless, this therapy brought about nice controversy, because the US Medicines Company opposed the opinion of a committee of consultants who believed that the therapy had not been confirmed efficient sufficient throughout medical trials. The company later banned its use, limiting it to individuals with gentle instances of the illness.

A latest report from the US Congress confirmed that the worth of the drug is excessive ($56,000 a 12 months), and the federal medical insurance system “Medicare” for the aged introduced that it’s going to not cowl its prices if it isn’t launched to the medical trials framework.