The Food and Drug Administration’s expected approval of Biogen and Eisai’s Alzheimer’s drug Leqembi, or lecanemab, is set to broaden access and accelerate a new class of treatments for the degenerative disease.
A number of patient advocacy groups are eagerly awaiting the decision, which would trigger broader access under Medicare. But the drug still faces coverage restrictions, along with critics who don’t believe it should be on the market at all.
The FDA is expected to decide by Thursday whether to fully approve the monoclonal antibody, which previously received accelerated clearance based on its ability to reduce amyloid beta plaque buildup in the brain. A small group of external advisers unanimously recommended the approval in May in a dramatic reversal from the reception the companies received for their last Alzheimer’s drug Aduhelm, or aducanumab.
