US regulators have approved an Alzheimer’s drug from Biogen that split the scientific community, marking a significant moment for sufferers of the disease and their families.
Aducanumab is designed for patients suffering from mild to moderate Alzheimer’s. Biogen claims it reduces the progression of the disease by breaking up clumps of amyloid plaques that form in the brain.
The treatment has been surrounded by controversy for years, and many scientists opposed its approval, saying it does not work.
The US Food and Drug Administration decision announced on Monday is monumental given that no new drug has been approved for the disease in years, and very few treatments exist. Nearly 6m people in the US suffer from Alzheimer’s.
“We are well-aware of the attention surrounding this approval,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, adding that “patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease”.
Trading in Biogen’s shares was halted ahead of the decision.
More to follow