A Rhode Island man on Wednesday got the first transfusion of a newly approved drug to treat Alzheimer’s — despite questions over the drug’s cost and effectiveness.
Mark Archambault, 70, is the first person outside of clinical trials to get a dose of Biogen’s Aduhelm, which is taken intravenously each month, can cost an average of $56,000 a year – and is not yet officially covered by Medicare.
Butler Hospital’s Memory and Aging Program gave the first dosage, Reuters reported.
“We are opening a new era in treatment,” said Dr. Stephen Salloway, Brown University Medical School neurology professor.
The drug’s approval last week by the Food and Drug Administration ruffled feathers, with some doctors telling the FDA to reject the drug. Three scientists on a panel advising the FDA resigned after the drug’s approval, reports said.
“This might be the worst approval decision that the FDA has made that I can remember,” Dr. Aaron Kesselheim said, according to the New York Times.
The drug, whose medical name is aducanumab, has only been tested on early-stage Alzheimer’s patients, even though the FDA OK’d its use for all Alzheimer’s patients. Some have questioned the drug’s efficiency compared to risks of side effects.
The Alzheimer’s Association called the price of the drug “simply unacceptable,” and the group’s chief public policy officer told Reuters most Medicare recipients are responsible for 20 percent of drugs and 10 percent have no cap on costs.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research responded to the scrutiny on the approval in a statement at the time.
“We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders,” she said.
“With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review.”
The new drug is the first approved treatment for Alzheimer’s in about 18 years and the first that doctors are hoping will not just lessen symptoms but target the underlying disease.
There were more than 120,000 deaths from Alzheimer’s in the US in 2019 — up over 50 percent from a decade earlier, according to the Centers for Disease Control and Prevention.
With Post wires.
Originally published at https://nypost.com/2021/06/16/first-patient-given-new-alzheimers-treatment-drug/ on .