That’s according to a clinic neurologist who studied the drug and has expressed concerns about its effectiveness.
“I’ve publicly expressed my views that I thought the data that showed there were clinical benefits were very weak,” Mayo Clinic neurologist Dr. David Knopman said of the treatment, whose generic name is aducanumab.
“We’re going to restrict it to people like those who were in the trial,” he said. “We’re not going to treat patients (with the drug) who are too severe, and we are not going to treat patients who are asymptomatic.”
An intravenous medication manufactured by Massachusetts-based drugmaker Biogen, the monoclonal antibody attacks amyloid plaque, dense proteins in the brain that are associated with the disease.
The drug is proven to reduce the plaque, a so-called biomarker of the illness, but critics question whether doing so will reduce clinical features such as memory loss and cognitive decline.
“The decision today by the FDA was to approve the drug based on the fact that it lowered brain amyloid levels,” Knopman said. “Even though there was no acknowledgment by the FDA that the drug had consistent clinical benefits for patients.”