The High Authority for Health rejects accelerated approval of the Alzheimer's drug Leqembi in France

Leqembi, a new treatment for Alzheimer's disease, will not be reimbursed immediately in France. The French National Authority for Health (HAS) ruled on Tuesday, September 9, against an accelerated approval procedure in France for Leqembi , an anti-Alzheimer's drug that is generating high expectations but far from unanimous support for its clinical benefits.

Leqembi (lecanemab) shows "modest efficacy (...) associated with a worrying tolerance profile", this independent authority estimates in an opinion, thus refusing an "early access" procedure for this treatment developed by the American Biogen and the Japanese Eisai.

This treatment has been the source of considerable medical controversy in recent years. Along with another drug with a similar effect, Kisunia (donanemab), developed by Eli Lilly, they are the first in several decades to demonstrate a slight slowdown in the deterioration of the condition of Alzheimer's patients.

Some experts believe these drugs represent a significant step forward in the fight against Alzheimer's disease, the most common form of dementia, with tens of millions of sufferers worldwide. Patient and family associations overwhelmingly support their approval. But other experts believe the benefits are too modest to make a difference for patients, especially since these treatments are frequently associated with serious side effects—hemorrhages and cerebral edema—that can be fatal.

Leqembi has been approved across the European Union (EU) since April , but European health authorities initially refused to give it the green light and then only gave it by restricting its use to patients at the lowest risk and only in the early stages of Alzheimer's disease.

In this context, the HAS had to decide on the merits of "early access" to Leqembi in France for patients with early-stage disease. This procedure allows for immediate reimbursement of the drug, at the price set by its manufacturer.

The health authority, whose opinions are only advisory but generally followed by the government, ultimately decided that there was no justification for such emergency approval because it deemed the side effects to be far too serious and frequent in comparison with the meager benefits.

"The treatment assessed is not likely to meet an insufficiently covered medical need," the HAS ruled.

This opinion does not, however, rule out the possibility that Leqembi may one day be reimbursed by health insurance. The HAS will later decide on a possible "common law" procedure, which would involve longer and more complex negotiations between manufacturing laboratories and health authorities.

But "it's clear that we can't expect a dazzling assessment," warned Pierre Cochat, president of the HAS transparency committee. Within the medical world, this decision has provoked mixed reactions, between those convinced of Leqembi and those skeptical of it.

"There is still some disappointment," admits researcher Bruno Dubois, a neurologist at the Pitié-Salpêtrière Hospital (AP-HP), to AFP, calling on people not to overlook the benefits of "a few more months of being able to talk to their grandchildren or go to the theater."

On the contrary, "it's the best decision for Alzheimer's patients and their families," British psychiatrist Rob Howard, a specialist in old age at University College London, told AFP. More recent data confirms that Leqembi and Kisunla "do not actually modify the disease."