The American Journal of Managed Care2d
FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...
pharmaphorum7d
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of ...
pharmaphorum9d
Biogen, Eisai double down on Alzheimer's with lecanemab filing
Like Aduhelm (aducanumab) lecanemab – also known as BAN2401 – is another amyloid-directed antibody but has a slightly different mechanism, targeting soluble amyloid beta protofibrils which ...
New Treatments for Alzheimer’s Disease
The drugs, aducanumab (Aduhelm) and lecanemab (Leqembi), were approved in June 2021 and January 2023, respectively. Both ...
Forbes1y
VA Will Cover Alzheimer’s Disease Drug Lecanemab, Provided A Detailed Set Of Inclusion And Exclusion Criteria Are Met
The VHA decision stands in contrast with Medicare’s National Coverage Determination (NCD) for amyloid-directed monoclonal antibodies, such as lecanemab and aducanumab. In April 2022, the Centers ...
ebm.bmj11mon
28 A perfect storm: expanded disease definitions in alzheimer’s disease and the new era of disease-modifying drugs in mild cognitive impairment
The first disease-modifying drug in AD, Aducanumab, was approved by the FDA in June 2021, followed by Lecanemab in January 2023. These approvals were based on reduction of amyloid β plaques with an ...
Seeking Alpha15d
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
Leqembi (lecanemab). It also abandoned the required post-market study on Aduhelm. The OIG report points out that for both eteplirsen and aducanumab, FDA evaluated analyses were not included in the ...