Cost Is Next Hurdle To Clear For Newly-Approved Alzheimer’s Drug Leqembi
The Food and Drug Administration granted accelerated approval Friday for Leqembi, developed by Eisai, for use in Alzheimer's patients with mild cognitive impairment or who at the mild dementia stage of the disease. The drug is priced at $26,500 annually and current Medicare rules would restrict coverage.
Stat:
FDA Approves New Alzheimer's Drug Leqembi
The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease. The drug, called Leqembi, was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago. (Feuerstein, 1/6)
NPR:
FDA Grants Alzheimer's Drug Leqembi Accelerated Approval
"This is a milestone for people eligible for this treatment, for their families, for the research community," says Maria Carrillo, chief science officer for the Alzheimer's Association. (Hamilton, 1/6)
USA Today:
FDA Approves Alzheimer's Drug Lecanemab From Eisai, Biogen
Eisai and Biogen sought the Food and Drug Administration’s accelerated approval for the amyloid beta-busting drug, lecanemab. Sold under the brand name Leqembi, the drug is priced at $26,500 per year for biweekly dosing. The treatment is intended for patients in early stages of the disease, which was the population studied in clinical trials. (Alltucker and Hassanein, 1/6)
On how the new drug is triggering worries over cost, access —
Stat:
The FDA Has Approved A New Alzheimer's Drug, But Wide Access May Depend On CMS Easing Restrictions
Now that the U.S. Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. (Silverman, 1/6)
The Wall Street Journal:
New Alzheimer’s Drug Leqembi Will Be Out Of Reach For Most Patients
A sweeping Medicare rule issued last year will keep the newly approved Alzheimer’s disease drug Leqembi out of reach of most U.S. patients for months to come. The Food and Drug Administration on Friday approved Eisai Co. and Biogen Inc.’s Leqembi, known generically as lecanemab, for the treatment of people with early-stage Alzheimer’s disease, the vast majority of whom are insured by Medicare. However, Medicare won’t pay for the drug unless patients are enrolled in government-sanctioned clinical trials, and no such studies are ongoing or planned. (Walker, 1/7)
In news on questions over the drug's abilities —
The Washington Post:
Alzheimer’s Drug That Slows Cognitive Decline Gets FDA Approval
The Food and Drug Administration on Friday approved an Alzheimer’s drug that slowed cognitive decline in a major study, offering patients desperately needed hope — even as doctors sharply debated the safety of the drug and whether it provides a significant benefit. (McGinley, 1/6)
AP:
EXPLAINER: New Drug Slows Alzheimer's But Comes With Caveats
A new Alzheimer’s drug is hitting the market — the first with clear-cut evidence that it can slow, by several months, the mind-robbing disease. It’s a long-needed new treatment, but experts also are voicing a lot of caution: The drug isn’t a cure, it’s only intended for early-stage patients, requires IV doses every two weeks, and comes with some safety concerns. (Neergaard and Perrone, 1/7)
