US regulators have approved an Alzheimer’s drug from Biogen that has divided the scientific community, marking an important moment for patients with the disease and their families.
Aducanumab is designed for patients with mild to moderate Alzheimer’s disease. Biogen claims to reduce disease progression by breaking up clumps of amyloid plaques that form in the brain.
The treatment has been surrounded by controversy for years, and many scientists have opposed approval for it, saying it doesn’t work.
The FDA’s decision it announced Monday is a monumental one given that no new drug for the disease has been approved for years, and few treatments exist. Approximately 6 million people in the United States have Alzheimer’s disease.
“We are well aware of the interest surrounding this approval,” said Patricia Cavazoni, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, adding that “Alzheimer’s patients have an important and critical new treatment to help fight this disease.”
Trading in Biogen shares was halted prior to the decision.