Los Angeles Times: FDA Approves Much-Debated Alzheimer's Drug Panned by Experts
The Los Angeles Times and pharmaceutical news site Fierce Pharma recently spoke with Zaldy Tan, MD, medical director of the Jona Goldrich Center for Alzheimer's and Memory Disorders at Cedars-Sinai, about a drug approved by the Food and Drug Administration to treat Alzheimer's disease despite a lack of evidence that it is effective at reversing cognitive decline.
Marketed under the name Aduhelm, the drug is the first medication approved in 18 years for Alzheimer's, which affects 6 million Americans. It aims to reduce plaque that builds up in the brain, causing memory loss and mental decline. Aduhelm failed to improve patients' symptoms in clinical trials, but the drug's developer said that a later analysis found it effective at higher doses.
While not a cure, Tan said he hopes Aduhelm will be a key step that spurs further research. “It will be the start of more investments, more attention, more focus on disease-modifying therapies directed at changing the course of Alzheimer’s disease,” Tan told the Times. "And perhaps one day, we will find a really effective and safe medication."
While academic scientists continue to debate Aduhelm's approval, Fierce Pharma noted that doctors in private practice are eager to prescribe it. But questions remain about how to manage high demand for the medication, which is given by IV infusion, and whether insurance companies will cover its high cost, estimated to be more than $50,000 a year.
"There are still many unknowns," Tan told Fierce Pharma.