FDA Could Soon Grant Approval To Another Experimental Alzheimer’s Drug
If the FDA greenlights Eisai's experimental dementia drug lecanemab under its accelerated approval pathway —as anticipated on Jan. 6 — experts look ahead to how much the treatment will cost.
FDA Decision On Experimental Alzheimer's Drug Expected This Week
Lecanemab -- one of the first experimental dementia drugs to appear to slow the progression of cognitive decline -- has shown "potential" as an Alzheimer's disease treatment, according to Phase 3 trial results, but raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding. (1/2)
With FDA Accelerated Approval Of Alzheimer’s Drug Lecanemab Likely January 6th, Discussion Turns To Price And Reimbursement
According to the Institute for Clinical and Economic Review (ICER), the beta amyloid-directed monoclonal antibody, lecanemab, must be priced lower than $20,600 a year to be cost-effective. Specifically, ICER’s calculations suggest that the Alzheimer’s Disease drug’s demonstrated benefits in a Phase 3 trial - a modest but statistically significant slowing of cognitive decline - are valued at between $8,500 and $20,600 per year. (Cohen, 1/2)
In developments on Alzheimer's drug Aduhelm —
Probe: Alzheimer's Drug Approval 'Rife With Irregularities'
The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” (12/29)
As Decision On New Alzheimer’s Drug Nears, Biogen Aims For Redemption
On Thursday, two congressional committees said the Food and Drug Administration’s review and 2021 approval of the earlier drug, Aduhelm, was “rife with irregularities,” including dozens of undisclosed calls and e-mails with Biogen that reflected an “inappropriate” level of coordination between the drugmaker and regulators. The congressional report also said Biogen tried to maximize its potential profit at the expense of patients and taxpayers when it priced the drug at $56,000 a year. (Cross, 1/1)
Congressional Report: U.S. FDA Broke Own Protocols In Approving Biogen Alzheimer's Drug
The FDA's interactions with Biogen were "atypical" and did not follow the agency's documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug's regulatory review, approval, pricing, and marketing. (Aboulenein, 12/30)