"It really is a new day for all of our constituents, so many who already have lost family members, so many who face Alzheimer’s today," said Johns. "I want to make clear this is not a cure. As in the case of so many other diseases, the first treatments are imperfect, but they can and do make a difference and that is very meaningful to those families."
Still unanswered are thorny questions about how doctors determine if a patient is eligible for the drug and whether patients will need to get expensive PET scans to detect amyloid beta plaque deposits in their brain.
"It’s going to be months before we know if anybody is going to pay for medication, the infusions, the MRIs, the PET scans that will be needed," said Dr. Pierre Tariot, director of the director of Banner Alzheimer’s Institute in Phoenix. "Who will be trained to disclose the amyloid information to the patient and the families? There’s a lot that has to be done."
The drug is a monoclonal antibody that works by removing amyloid beta from the brain. Scientists have long theorized plaques formed by these protein deposits in the brains of Alzheimer's patients kill brain cells and lead to cognitive decline. However, drug companies have invested billions on drugs that target or remove amyloid but have not yet proven the drugs slow memory and thinking problems.
The FDA said the approval of Aduhelm is based on a "surrogate endpoint" that the drug effectively removed amyloid plaque from the brain. Such an endpoint predicts but does not measure whether the drug will slow memory or thinking decline.
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