Leqembi, the Alzheimer’s drug authorized by the FDA under an expedited procedure
The FDA-approved Alzheimer's drug raises some doubts and Biogen, which produced it together with Eisai, had already created another that had caused discussion. All the details
Despite some doubts, the drug from the Japanese Eisai and the US Biogen against Alzheimer's has obtained approval from the Food and Drug Administration (Fda) through an accelerated procedure.
The monoclonal antibody, whose active ingredient is called lecanemab, will be marketed under the name of Leqembi.
THE DRUG
The drug, as the companies explain , is an antibody designed to tell the immune system to clear beta-amyloids from the brain. These, in fact, are proteins which, by aggregating in the spaces between the neurons of the brain, form plaques, which can initiate or enhance the processes of Alzheimer's disease.
I STUDY
Researchers evaluated the effectiveness of Leqembi in a double-blind, placebo-controlled, parallel-group, and dose-control study of 856 patients with mild cognitive impairment or mild dementia.
THE RESULTS
The study found that patients receiving the approved dose of lecanemab (10 milligrams/kilogram) every two weeks experienced a "statistically significant" reduction in plaques compared to the placebo group, which did not.
This means that the drug is able to slow down the course of the disease.
SIDE EFFECTS
One of the reported side effects is amyloid-related imaging abnormalities (ARIA for short), a common side effect with other monoclonal antibodies.
The most common symptoms of ARIA are temporary swelling in areas of the brain, which usually resolves over time and may be accompanied by small patches of bleeding within or on the surface of the brain. Some people may also have symptoms such as headache, confusion, dizziness, vision changes, nausea, and seizures.
THE COST
Eisai, who is solely responsible for setting the price, Pharmastar reported, said Leqembi's list price will be $26,500 annually. The figure is slightly lower than that of Aduhelm – another of Biogen's Alzheimer's drugs cleared by the FDA in 2021 – but higher than recommended by some analysts.
"Based on our draft results, this price would fall short of typical cost-effectiveness thresholds," said David Rind, chief physician at the Institute for Clinical and Economic Review, an independent nonprofit that assesses value. of the drugs and that in an earlier report he said the price should be set at between $8,500 and $20,600 a year.
THE DOUBTS
Although the authorization of an Alzheimer's drug is considered by the scientific community to be a revolution since attempts so far have almost always failed, enthusiasm is accompanied by caution.
In fact, Leqembi, as Start wrote about a month ago, caused infusion-related reactions in 26.4% of participants and beta-amyloid-related imaging abnormalities with edema or effusions in 12.6%. Brain scans also revealed a risk of brain hemorrhage (17% of participants) and brain swelling (13%). 7% of people given the drug had to stop it due to side effects.
Finally, the drug has so far been tested – and is therefore recommended – only in patients with early-stage disease. Alzheimer's unfortunately, however, is not easy to identify and often the diagnosis comes later.
BECAUSE AN ACCELERATED PROCEDURE HAS BEEN USED
The FDA uses the accelerated approval process for drugs for serious conditions where the medical need is not met. However, they must achieve goals and provide a clinical benefit for patients.
THE SHIPPING DRUG AND BIOGEN'S REPUTATION
Biogen, as anticipated, in 2021 had received FDA authorization for Aduhelm, another drug against Alzheimer's. However, expert doubts meant that in the United States it was excluded from the Medicare government health program, thus denying insurance coverage for the drug, and in Europe it never received authorization, ultimately remaining unused. The fear is that now the same thing will happen with Leqembi.
Furthermore, the manifesto specifies, “the precedent of the approval of Aduhelm weighs above all on Biogen's reputation. That controversial decision caused the controversial resignations of three FDA experts and led to a US parliamentary inquiry. The conclusions, published on December 30, show that the assessment was 'definitely atypical' and influenced by the close relations between the company's top management and FDA experts. Now the ball passes to the European Medicines Agency (EMA). Eisai has communicated that the authorization request will be presented to the EMA by March 2023".
A COMPETITOR IS COMING
Meanwhile, another anti-amyloid drug for Alzheimer's could be on the way, according to Pharmastar . It's Eli Lilly's donanemab and it's speculated that it could get accelerated approval by February.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/leqembi-il-farmaco-contro-alzheimer-autorizzato-dalla-fda-con-una-procedura-accelerata/ on Mon, 09 Jan 2023 13:30:13 +0000.