(INDIANAPOLIS) – The FDA has approved the first new Alzheimer’s drug in 18 years — but not without controversy.
An FDA advisory committee had voted 10-1 against approving Aduhelm, arguing there’s not enough evidence it works. Two trials produced opposite results. Eight of the 11-panel members argued even the “good” study didn’t deliver enough benefits to be worthwhile.
But IU School of Medicine Alzheimer’s researcher Liana Apostolova says she believes the FDA made the right call, allowing the drug to come to market while ordering another round of trials to confirm its benefits. She notes the Alzheimer’s population is exploding as the baby boomers age, and no new therapy has been approved since 2003. She says the disease will bankrupt Medicare if researchers don’t come up with successful treatments. She says Aduhelm shows enough promise that patients shouldn’t have to wait four or five years for another trial to be completed.
And Apostolova says the probationary approval isn’t a rubber stamp. She says in 200 cases where the FDA has taken this approach, the agency revoked the approval in 8% of them after unsatisfactory results in the additional trials.
Advisory panel members and some other researchers have also questioned whether Aduhelm’s benefit is enough to outweigh side effects. Two out of five patients had brain swelling or bleeding. But most of them didn’t have any symptoms, and Apostolova says doctors can reduce the dosage if those side effects occur.
The positive trial suggested Aduhelm slows the progression of Alzheimer’s by four to seven months. While that may not sound like much, Apostolova says any gain against Alzheimer’s effects is significant. And she says if the drug’s effects are cumulative, the eventual benefits will be much larger.
