The Food and Drug Administration’s approval of Biogen Inc.’s Aduhelm on Monday may have boosted the prospects of other experimental Alzheimer’s disease drugs that target the disease in a similar way.
In greenlighting Aduhelm, the FDA endorsed a hypothesis about Alzheimer’s that not long ago was thought dead: The disease can be treated by clearing the buildup of a sticky substance in the brain known as amyloid.
Many scientists studying Alzheimer’s aren’t ready to give up on the amyloid hypothesis, but there isn’t a consensus on precisely what role amyloid plays in the disease.
In approving Aduhelm, the FDA said the drug reduced amyloid and thereby likely helps Alzheimer’s patients.
The decision was cheered by many Alzheimer’s patient groups and doctors, who have lacked good options for treatment. The move was criticized, however, by many researchers who said there wasn’t enough evidence to show the drug worked and at a $56,000 yearly list price, it will be costly.