The Food and Drug Administration changed its recommendations for the newly approved Alzheimer’s drug Aduhelm after an intense public backlash. The agency modified the prescribing instructions for the drug to limit its use and efficacy only to patients with mild to moderate Alzheimer’s disease.
The FDA’s decision to clarify the drug label is a big change from its original stance last month when it approved Aduhelm for Alzheimer’s disease in general, according to NBC News. But after protests poured in from medical experts and healthcare officials, the agency tightened the recommendations for use of the drug. One Harvard expert called the original, broad-based decision the “worst drug approval decision in recent U.S. history.”
“Hearing these concerns, FDA determined the clarifications could be made to the prescribing information to address this confusion,” the agency said, adding that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s.
According to Axios, Aduhelm is manufactured by Biogen and administered by an intravenous solution at an annual cost of $56,000 per patient. Critics questioned the wisdom of approving this drug not only for its exorbitant cost but also for its limited efficacy, according to an analysis by Altarum, a non-profit research and consulting healthcare organization.
Dr. Sam Gandy, a professor of Alzheimer’s research at the Icahn School of Medicine at Mount Sinai in New York, said he was shocked when the FDA ignored the advice of its neurological drugs advisory panel and approved the Biogen drug.
In an opinion article he wrote for STAT News, the neurologist said approving Aduhelm was a mistake and added that three members of the FDA advisory committee resigned in protest over the decision to give the drug a much broader use than its original purpose.
Still, for the millions of Americans with early stages of the disease, approval of the new drug with the generic name of aducanumab, signals “the beginning of a new future,” said Kristen Clifford, the chief program officer for the Alzheimer’s Association, according to AARP. “We know that slowing decline, particularly with early diagnosis, could add days, weeks, months, maybe even years of active life for individuals and families.”
It is unknown how many Americans will have access to the pricey drug, and if Medicare will cover the cost of Aduhelm that needs to be delivered intravenously. Last November, according to AARP, the FDA initially nixed the drug after two identically designed clinical trials resulted in different conclusions. The first study found that patients with early or mild stages of Alzheimer’s who were given high doses of aducanumab showed improvement in performing everyday tasks. The second study did not have the same positive outcomes.
According to NBC, Aduhelm has not been shown to reverse or significantly slow down the progress of the disease. The FDA says the drug may reduce plaque in the brain that could impede the progression of the disease, but there is no scientific evidence to support that claim.
“It was pretty troubling that the previous label was so broad and included groups of patients in whom the drug had never been tested,” said Dr. Suzanne Schindler, a neurologist who specializes in neurogenerative disorders such as Alzheimer’s disease. “I think this is a positive change because it better reflects the patients in whom the drug was actually studied.”