Expectations were sky-high ahead of the decision. But when the news came last week that the drug lecanemab would not be approved by the European Medicines Agency (EMA), it was a cold shower for patients and their relatives. This is according to Liselotte Jansson, Secretary-General of the Alzheimer's Foundation.
Many are very sad and disappointed. When this brake medicine is finally available, it's idiotic to stop it, especially since it has been approved by several other countries.
According to Liselotte Jansson, the rejection means that valuable time is being lost.
Patients with Alzheimer's do not have time on their side, it is their worst enemy.
A Tough Nut to Crack
In Alzheimer's, plaques form in the brain in the form of the protein beta-amyloid, which accumulates. Lecanemab has been long-awaited because it consists of antibodies that target the protein specifically, unlike today's medicines.
But the high expectations of the medicine have not been met, according to Alzheimer's researcher Hugo Lövheim at Umeå University.
Although lecanemab affects the underlying causes of Alzheimer's, the effect on patients' symptoms and disease progression has not been significant.
The motivation behind EMA's decision is that the benefit is not sufficient in relation to potential drawbacks and side effects, such as swelling and risk of bleeding in the brain.
The benefit is not that great, while the risks are not insignificant. So for us researchers, the decision is not entirely surprising, says Lövheim.
He continues:
Research has been going on for a long time, but Alzheimer's has proven to be a tough nut to crack. It has to do with the fact that we still don't have sufficient knowledge of the disease's various mechanisms.
The Final Word Not Said
He emphasizes that EMA's task is to protect patient safety.
It's clear that patients and their relatives have high hopes for new and better treatments. But amidst all the disappointment, one must remember how important it is for authorities to conduct their independent investigations.
The drug has previously been approved in, among others, the USA, Japan, and China. The Swedish company Bioarctic, which is behind the discovery that led to the drug, has announced that a review of the decision has been requested.
Hugo Lövheim does not rule out that there may be a change.
I don't think the final word has been said. If additional data that has not been presented before is added, it may change the picture.
Lecanemab has been approved in the USA, Japan, South Korea, China, Hong Kong, and Israel.
But the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) believes that the observed effect of slowing down cognitive decline does not outweigh the risk of serious side effects associated with the medicine.
Lecanemab, marketed under the brand name Leqembi, has been developed by the American pharmaceutical company Biogen and the Japanese company Eisai.
The drug is based on a discovery by Swedish researcher Lars Lannfeldt, professor at Uppsala University. The medicine has been developed, among others, by the Swedish company Bioarctic, which Lars Lannfeldt co-founded. Bioarctic receives a royalty on the global sales of lecanemab.
Sources: Dagens Medicin and others.
Among the dementia diseases, Alzheimer's disease is the most common. It is also quite common for Alzheimer's disease to occur in combination with vascular dementia (vascular dementia).
What they have in common is that they all involve problems with memory functions.
In Sweden, over 100,000 people have Alzheimer's disease.
The most important risk factors are high age and heredity.
In the disease, small clumps form on the nerve fibers, so-called amyloid plaques. They consist mainly of beta-amyloid, a type of protein. The plaques that form in the brain cells lead to nerve cells in the brain dying abnormally quickly.
Alzheimer's typically occurs after the age of 65. But it can also affect younger people, as early as in their 35s.
Sources: Alzheimer's Foundation, Demenscentrum, and others.
