FDA Approves New Drug To Treat Alzheimer's Disease
By Bill Galluccio
June 7, 2021
The Food and Drug Administration has approved a new drug to treat people suffering from Alzheimer’s disease. The drug, which goes by the name aducanumab and was made by Biogen, is the first drug approved to slow the cognitive decline caused by the disease.
It is the only approved drug to treat the disease and not just the underlying symptoms such as anxiety and insomnia.
The drug targets a sticky compound in the brain known as amyloid-beta, which plays a role in the cognitive decline of patients. The treatment involves receiving a transfusion once a month.
Alzheimer’s disease is a progressive neurodegenerative disorder and is the sixth leading cause of death in the United States. The Alzheimer’s Association estimates that six million Americans have been diagnosed with the illness, and the group expects that number to rise to 13 million by 2050.
Aducanumab has had a long and controversial road to approval. Biogen stopped working on the drug in March 2019 after an independent group determined the drug was unlikely to work. Several months later, Biogen reversed course and said it would seek approval for the drug, citing a new study that found it “reduced clinical decline in patients with early Alzheimer’s disease.”
“We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.”
“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,” Cavazzoni added.
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