Leqembi

The drug, Leqembi, may modestly slow cognitive decline in early stages of the disease but carries some safety risks. Still, data suggests it is more ...

The authors reported that “serious adverse events” occurred in 14 percent of Leqembi patients and 11 percent of those receiving a placebo. is ubiquitous” in Alzheimer’s, it made sense to allow patients to use Leqembi with appropriate monitoring because it was the anti-amyloid monoclonal antibody with the lowest rate of brain swelling and bleeding so far. About 17 percent of Leqembi patients experienced brain bleeding, compared with 9 percent of patients receiving the placebo. “From the perspective of a scientist, it is exciting that an experimental treatment targeting brain amyloid in Alzheimer’s disease appears to slow cognitive decline,” Dr. can give accelerated approval to drugs with uncertain benefit if they are for serious diseases with few treatments and attack a biological element of the disease — in this case, the amyloid protein. also requested more data on subgroups of patients characterized by age, gender, health status and other factors, and that it worked with the companies to include more diversity in the clinical trials. Ivan Cheung, the chairman and chief executive of Eisai’s United States operations, said in an interview that in discussing who should be eligible for the treatment, “we have worked very hard with the F.D.A. [report this week in the New England Journal of Medicine](https://www.nejm.org/doi/full/10.1056/NEJMc2215148?query=recirc_curatedRelated_article), involved a 65-year-old woman who had a stroke and, after receiving a standard treatment for stroke-related blood clots known as t-PA, experienced serious brain bleeding and died a few days later. It instructs doctors not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer’s: a buildup of the protein amyloid, which Leqembi (like Aduhelm) attacks. [investigation](https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html) by two congressional committees found that the approval process for Aduhelm was “rife with irregularities” and involved an unusually close collaboration with Biogen. In a preliminary report last month, the institute said that to be cost-effective for patients, the price should be set between $8,500 and $20,600 a year. The approval of the drug, lecanemab, to be marketed as Leqembi, is likely to generate considerable interest from patients and physicians.

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was ...

The maximum radiographic severity of ARIA-E in patients treated with LEQEMBI was mild in 4% (7/161) of patients, moderate in 4% (7/161) of patients, and severe in 1% (2/161) of patients. The maximum radiographic severity of ARIA-H microhemorrhage in patients treated with LEQEMBI was mild in 4% (7/161) of patients and severe in 1% (2/161) of patients; 1 of the 10 patients with ARIA-H had mild superficial siderosis. Some people may also have small spots of bleeding in or on the surface of the brain (ARIA-H) with the swelling. Infusion-related reactions resulted in discontinuations in 2% (4/161) of patients treated with LEQEMBI. - Infusion-related reactions were observed in LEQEMBI: 20% (32/161); placebo: 3% (8/245), and the majority of cases in LEQEMBI-treated patients (88%, 28/32) occurred with the first infusion. Caution should be exercised when considering the use of LEQEMBI in patients with these risk factors. Because intracerebral hemorrhages >1 cm in diameter have been observed in patients taking LEQEMBI, additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. - The incidence of ARIA was higher in ApoE ε4 homozygotes than in heterozygotes and noncarriers among patients treated with LEQEMBI. The most common adverse reactions reported in at least 5% of patients treated with LEQEMBI 10 mg/kg biweekly (N=161) and at least 2% higher incidence than patients on placebo (N=245) were infusion-related reactions (LEQEMBI 20%; placebo 3%), headache (LEQEMBI 14%; placebo 10%), ARIA-E (LEQEMBI 10%; placebo 1%), cough (LEQEMBI, 9%; placebo, 5%) and diarrhea (LEQEMBI, 8%; placebo, 5%). The most common adverse reaction leading to discontinuation of LEQEMBI was infusion-related reactions that led to discontinuation in 2% (4/161) of patients treated with LEQEMBI compared to 1% (2/245) of patients on placebo. Clinical symptoms associated with ARIA resolved in 80% of patients during the period of observation. Eisai is developing a multi-faceted educational initiative to further advance the understanding in the AD healthcare community of the real-world management and monitoring of ARIA.

Eisai and Biogen plan to soon ask for full approval based on recent results from a large clinical trial that showed Leqembi significantly slowed decline versus ...

Adoption “will increase gradually over the mid-to-long term given the time required to advance new screening and diagnostic technologies,” Eisai added. Eisai and Biogen plan to soon ask for full approval based on recent results from a large clinical trial that showed Leqembi significantly slowed decline versus a placebo. [the policy](https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305), coverage for Alzheimer’s drugs approved on an accelerated basis, as Leqembi was, is restricted only to patients who are enrolled in a clinical trial. In the near term, though, very few patients will be able to receive insurance coverage for treatment. In notes to clients, analysts on Wall Street described Eisai’s assumptions as conserative, forecasting sales could reach several hundred million dollars by next year. (Unlike with Aduhelm, Eisai led Leqembi’s development and was responsible for setting its price.) For Eisai, the pharmaceutical developer behind the drug, the approval is both a major milestone and a significant test. “Eisai decided to price Leqembi below quantified societal value at the wholesale acquisition cost of $26,500 per year ... Upon securing approval, the company issued a A successful market launch of the medicine, called Leqembi, could change the Japan-based company’s future. who are diagnosed with the memory-robbing condition each year. Biogen

The drug, called Leqembi, was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer's 25 ...

Eisai restricted the study of Leqembi to people with mild cognitive impairment or early stage Alzheimer’s that also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. “The effect size is minimal and may not be perceptible to patients or caregivers over the 18 months shown in the trial. Eisai has the final decision-making power on all matters — scientific and business — related to Leqembi. Some data from Eisai’s clinical trial suggested that approximately 10% of people who carry two copies of APOE4, the most common genetic risk factor for Alzheimer’s, don’t benefit from Leqembi and may actually be harmed by it. But Alzheimer’s hasn’t seen [real medical progress in decades](https://www.statnews.com/2022/10/20/front-of-alzheimers-patients-in-successful-drug-trial/), so even with limitations, the drug is groundbreaking and a reason for cautious optimism. “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. In the 18-month study, Eisai’s drug also dramatically reduced levels of beta-amyloid, a toxic protein in the brain thought to drive the advance of Alzheimer’s. “I will prescribe it for the right patient. The new approval “feels like the beginning of something important, like maybe now we can get some momentum.” The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it. Biogen, the Cambridge, Mass.-based biotech, will co-market the drug with Eisai under a long-standing partnership. Leqembi will cost $26,500 per year for a person of average weight, Eisai said.