The agency approved the drug using “accelerated” approval, similar to the consideration it gave the coronavirus (COVID-19) vaccines that received emergency use authorization (EUA) last year.
The FDA said the accelerated approval pathway can be used for a drug for a serious or life-threatening illness that provides “a meaningful therapeutic advantage over existing treatments.”
The drug is intended to reduce amyloid plaque, a substance in the brain that has been associated with Alzheimer’s. Scientists tested the drug in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease.
The FDA said patients receiving the treatment had a significant reduction of amyloid beta plaque but patients in the control arm of the studies had no reduction of amyloid beta plaque.
‘Victory for people living with Alzheimer’s’
“This approval is a victory for people living with Alzheimer’s and their families,” said Harry Johns, CEO of the Alzheimer’s Association. “This is the first FDA-approved drug that delays decline due to Alzheimer’s disease. This means individuals may have more time to actively participate in daily life, have sustained independence, and hold on to memories longer.”
The drug is produced by Biogen and Eisai, Co., Ltd., a Japanese biopharma firm. Biogen CEO Michel Vounatsos called the FDA approval “a historic moment.”
“We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come,” Vounatsos said. “We are grateful for the contributions of thousands of patients and caregivers who participated in our clinical trials, as well as for the dedication of our scientists and researchers.
Critics’ concerns
The accelerated path Adihelm followed to its FDA approval has drawn concern from some critics who noted that it is an abrupt departure from how other drugs are brought to the market. The nonprofit group Public Citizen was particularly scathing in its rebuke.
“The FDA’s decision shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “Because of this reckless action, the agency’s credibility has been irreparably damaged.”
In addition, some doctors interviewed by the Wall Street Journal cautioned that the drug won’t be effective for every Alzheimer’s patient.
It will also be an expensive medicine. Biogen said that the typical patient would pay about $56,000 a year before insurance coverage for treatment with the drug. Cigna has estimated eligible patients may face $10,000 a year in out-of-pocket costs.
In 2021, the Alzheimer’s Association estimates about 6 million Americans are living with Alzheimer’s disease, which is a progressive cognitive illness for which there is no cure.