The US is the first country in the world to approve the pioneering Alzheimer’s drug lecanemab
US health officials today approved the first Alzheimer’s drug shown to slow the condition — in what could be a breakthrough for millions of patients.
Lecanemab, sold under the brand name Leqembi, immediately becomes the most effective treatment on the market after it received accelerated approval from the Food and Drug Administration (FDA) on Friday.
The drug, sold by pharmaceutical giants Eisai and Biogen, showed the ability to slow the progression of Alzheimer’s and clear plaques from the brain thought to be responsible for the disease.
In clinical trials, those who received the drug worsened 27 percent less than those in the control group.
The drug has been considered by some experts to be a game changer in the treatment of Alzheimer’s because there aren’t many options available to slow down the disease. Eisai announced that the price will be $26,500 for a full year of treatment.
However, some experts have cast doubt on the drug’s effectiveness, and safety concerns have been raised after three patients died in clinical trials. Last year, Biogen’s Alzheimer’s drug Aduhelm was widely criticized after it was given the green light by the FDA.
The FDA has approved Eisai and Biogen’s new Alzheimer’s drug lecanemab for use in early- and mid-stage patients. It slowed disease progression by 27 percent over 18 months in clinical trials (file photo)
“Alzheimer’s disease immeasurably impacts the lives of those who suffer from it and has a devastating impact on their loved ones,” said Dr. Billy Dunn, who works at the FDA’s Center for Drug Evaluation and Research, in a statement.
“This treatment option is the latest therapy that targets and affects the underlying disease process of Alzheimer’s, rather than just treating the symptoms of the disease.”
The drug’s development and research was conducted by Eisai, a company based in Tokyo, Japan. It has partnered with Biogen of Cambridge, Massachusetts, to commercialize it.
After approval, the FDA recommended using the drug in patients who are in early and mid-stage Alzheimer’s disease. This includes at least 1.5 million of the 6.5 million Americans who have been diagnosed with the disease.
Phase III clinical trials included 1,795 patients with early-stage Alzheimer’s disease. Half of the participants received 10 mg/kg of the drug every two weeks. The other group received a placebo instead.
The researchers measured the participants’ memory, judgment and problem-solving skills before the start of the study and again after 18 months.
They found that those taking the drug deteriorated at a 27 percent slower rate than those taking the placebo.
“The study data showed that lecanemab has a small but measurable impact on slowing the progression of Alzheimer’s,” Hillary Evans, chief chef at Alzheimer’s Research UK, said in a statement.
“In practice, the benefits of lecanemab will likely be measured in extra months rather than years. But as anyone with Alzheimer’s knows, that time can be precious.”
Regulators in the UK are expected to clear the drug for use later this year.
However, it came with some dangers. One in eight participants taking lecanemab experienced brain swelling, compared with one in fifty members of the control group.
However, those cases were not symptomatic, according to the company couple behind the drug.
Microbleeds, or small bleeds in the brain, were twice as common in the lecanemab group as in the placebo group – 17 percent suffered from them.
The drug’s label will also include warnings against using blood thinners while using lecanemab – a known risk for drugs that target amyloid beta plaques in the brain.
Two out of three patients who died from brain hemorrhage and swelling in clinical trials were also treated with blood thinners.
Deaths occurred at the end of the study, when they knew they were being treated with the drug and not a placebo.
However, the promising experiments have excited many experts. There are currently no effective treatments for Alzheimer’s itself — and doctors typically only help patients manage symptoms as they continue to lose weight.
The Institute for Clinical and Economic Review, which assesses the value of drugs, said the drug’s value ranges from $8,500 to $20,600 per year. This makes Eisai’s set price of $26,500 an oversold.
Last year, the FDA approved Aduhelm for the treatment of Alzheimer’s. The controversial approval was widely criticized by experts after dubious results in studies.
This drug targeted amyloid plaques in the brain that had already formed. The formation of these deposits in the brain is believed to be responsible for cognitive decline.
Lecanemab instead targets the proteins that make up these plaque deposits before they clump together, leading experts to hope it will be more effective than its predecessor.
However, the Aduhelm debacle left a sour taste in some Americans.
A congressional investigation last week found the drug’s approval process was “riddled with irregularities.”
“The findings in this report raise serious concerns about FDA protocol errors and Biogen’s disregard for efficacy and access in the approval process for Aduhelm,” said the report, which was prepared by staff on the House Committee on Oversight and Reform and Trade that was created by the House Committee on Energy was completed.
How does lecanemab work? When will it be rolled out? And is it dangerous?
what does it do
Lecanemab is given as an infusion every two weeks to patients in the earliest stages of Alzheimer’s disease.
It’s designed to clear a buildup of amyloid protein – toxic plaques in the brain thought to cause the cruel, memory-sapping disease.
The antibody treatment, which tells the immune system to clear amyloid from the brain, is made by Japanese and US pharmaceutical companies Eisai and Biogen.
What have tests shown?
The phase III study of lecanemab evaluated the drug’s ability to reduce cognitive and functional decline in 1,795 patients with early-stage Alzheimer’s disease.
Half of the participants received 10 mg/kg of the drug every two weeks, while the others received a placebo.
The researchers measured memory, judgment, problem solving, and judgment of all participants before the start of the study and again 18 months later.
The results showed that those who received lecanemab worsened 27 percent less than those who received the sham treatment.
Lecanemab recipients also experienced a slower buildup of amyloid in their brains, scans showed.
The findings were presented at a medical conference in San Francisco and published in the prestigious New England Journal of Medicine.
Is the drug dangerous?
In addition to promising results, the study also highlighted some safety concerns.
Brain swelling was noted in 12.5 percent of the lecanemab group, compared with 1.7 percent in the placebo group.
Although it showed up on scans, many of those cases weren’t symptomatic, Eisai and Biogen pointed out.
The data also showed that microbleeds in the brain, or mini-cerebral bleeds, occurred in 17 percent in the lecanemab group, compared with 8.7 percent in the placebo group.
Pharma chiefs insisted the numbers were within an expected range.
Two patients also died while taking lecanemab during the study in events under investigation.
However, Eisai and Biogen noted that all available safety information shows that the therapy is not associated with an increased risk of death.
How does it differ from the similar drug Aduhelm?
Both Aduhelm and lecanemab — both made by Eisai and Biogen — are antibodies designed to remove amyloid deposits.
However, lecanemab targets amyloid that hasn’t yet clumped together.
Aduhelm removes amyloid plaques that have built up in the brain.
The approval of Aduhelm was a rare bright spot for Alzheimer’s patients, but critics have warned of the drug’s disappointing results and highlighted its risks.
Aren’t there already medications for Alzheimer’s?
There is currently no treatment for Alzheimer’s, and decades of attempts have repeatedly failed to find a successful treatment.
However, medication is doled out to stave off telltale symptoms.
Nearly 7 million Americans suffer from dementia – up to three quarters of cases are thought to be caused by Alzheimer’s disease.
https://www.dailymail.co.uk/health/article-11607771/US-country-world-approve-gamechanger-Alzheimers-drug-lecanemab.html?ns_mchannel=rss&ns_campaign=1490&ito=1490 The US is the first country in the world to approve the pioneering Alzheimer’s drug lecanemab