U.S. health regulators approved the first new Alzheimer’s drug in nearly two decades, casting aside doubts about the therapy’s effectiveness.
The approval of the therapy, which has the molecular name aducanumab and will be sold as Aduhelm, marked a watershed in Alzheimer’s drug research after billions of dollars in investment. Maker Biogen Inc. developed the therapy to do what previously approved Alzheimer’s medicines can’t: slow the memory-robbing march of the disease.
The U.S. Food and Drug Administration, explaining its decision, said scientific evidence indicated Aduhelm reduces a sticky substance in the brain called amyloid—which is associated with Alzheimer’s—and is likely to produce a benefit to patients.
The drug’s sale offers hope to millions of people dealing with Alzheimer’s and their caregivers, given the lack of good options for treatment. Yet Aduhelm’s impact may be limited. Doctors who say they will prescribe the drug caution it won’t help all patients, particularly those with more advanced disease. Some patients eligible for treatment may face $10,000 or more in annual out-of-pocket costs.
Alzheimer’s is a progressive degenerative disease that slowly robs people of their memory and the ability to care for themselves.
About six million people suffer from Alzheimer’s in the U.S. Of those, as many as 1.4 million could be eligible to take Aduhelm.
Despite considerable effort and investment, researchers have struggled to find drugs that prove to treat Alzheimer’s. One drug after another aiming to slow the progression of the disease has failed in testing. The FDA last approved a new Alzheimer’s drug in 2003.
Before prescribing Aduhelm, doctors will want to first make sure their patient’s brain has amyloid buildup, which typically requires an imaging scan or spinal tap that usually aren’t covered by medical insurance.Unlike other Alzheimer’s drugs delivered in pills that can be picked up at a pharmacy, Aduhelm requires monthly infusions at a clinic. Patients will require monitoring with magnetic resonance imaging, or an MRI, to guard against small brain bleeds, a potential side effect of the drug.