June 24, 2021 | Vox
The new Alzheimer’s drug is the first of its kind. Will it be the last?
The FDA’s recent approval of the Alzheimer’s drug aducanumab is a crucial crossroads in the continuing search for a cure for this devastating disease.
Federal regulators approved Biogen’s drug, through an accelerated process, earlier this month. The FDA’s approval came over the objections of its own scientific advisers, who had cited a lack of evidence for the drug’s effectiveness. (Several of those advisers have since resigned.) Patient advocates, on the other hand, welcomed the decision because, to date, there is no treatment that clearly slows down the progression of this disease afflicting 6 million Americans. Health policy experts worried, almost immediately, whether an expensive drug of unproven efficacy would send costs for Medicare and private insurance soaring.
But beyond the immediate effects of aducanumab alone, there is another question lurking after the FDA’s decision: Will this ultimately lead to more drug development for Alzheimer’s disease — or less?
Several experts I spoke to [maintained] that aducanumab could lead to less drug development. For one, drug makers may not think it’s worthwhile to invest the time and money to find more effective treatments. Biogen cleared a low bar to get the FDA to sign off on its drug, and now it’s setting the list price at nearly $60,000 a year.
“Maybe now some companies will see that they can get Alzheimer’s drugs approved, so they will start (or keep) investing in that space,” Holly Fernandez Lynch, who studies drug development at the University of Pennsylvania, told me over email. “Maybe some of their drugs will work. But they will have little incentive to prove that definitively if FDA doesn’t make them.”
On top of that, a lot of Alzheimer’s patients — millions, maybe — could now be prescribed aducanumab. Patients understandably take FDA approval to be a sign that a drug works and so, believing now that Biogen’s drug does, they could be reluctant to participate in future trials, whether confirmatory trials for this drug (in which case they risk being randomized to a placebo) or for different, unproven treatments.
“If you want to do a trial of different drugs, all your patients are still going to want aducanumab. So you have to start testing different drugs against it or in addition to it,” Lynch Fernandez says. “That’s going to make it a hell of a lot harder to tell if the new drugs work. There is a lot of negative potential when FDA lowers its standards.”