Biogen and Aduhelm have certainly taken a lot of heat here in the United States, but they just took another hit over in Europe.
The Committee for Medicinal Products for Human Use, or CHMP, recommended that the European Medicines Agency not approve Aduhelm to treat Alzheimer’s disease. They acknowledged that it does remove beta amyloid plaques from the brain, but Biogen has not yet shown that the treatment actually improves cognition. Biogen will be asking CHMP to reconsider its decision. (We noted CHMP's intention previously, but this news makes it official.)
In the US, the FDA approved the monoclonal antibody treatment, while acknowledging that Biogen still needed to show that it actually works. And that will be a long process. Biogen recently announced that they are beginning a new, international placebo controlled trial. As we've seen before, ambiguous trial results lead to a protracted process of trying to understand the data. I wonder if other, more effective treatments might move into center stage before Biogen can achieve this.
Not surprisingly, Biogen has been forced to drop the price of Aduhelm treatment from $56,000/year to $28,200 per year.
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