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FDA approve Biogen’s Alzheimer’s drug

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Biogen’s Alzheimer’s disease drug aducanumab was approved by the Food and Drug Administration on Monday, marking the first new treatment for the disease in nearly two decades.

The drug, known as Aduhelm, was the first to be approved by US regulators to slow cognitive decline in people with Alzheimer’s disease nearly two decades ago. Acuranumab’s list price is $56,000 per year, or $4,312 per infusion, according to the Massachusetts-based biotechnology company.

The FDA’s decision was widely anticipated, and it gives friends and families of patients with the disease new hope.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release, “We are well-aware of the attention surrounding this approval.” “We understand Aduhelm has attracted the attention of the press, Alzheimer’s patients, our elected officials, and other interested parties.”

“It’s understandable that so many people were watching the outcome of this review because a treatment for a serious, life-threatening disease was on the line,” Cavazzoni added.

The FDA stated that it will continue to monitor the drug as it enters the market in the United States. The FDA approved Biogen’s application on the condition that it conduct another clinical trial.

Based on findings from a post hoc analysis, Biogen resurrected its once-failed Alzheimer’s disease drug in the year 2020. The company’s hopes for a quick FDA approval appear to be dashed, according to Fierce Biotech.

The drug had been heavily criticized by the FDA’s own panel of independent advisors. The data supporting the drug application was dissected by a panel of outside experts, who gave it a mixed rating. Biogen’s treatment, they claimed, had not been proven effective enough to earn the agency’s approval.

In both studies, the FDA found that aducanumab “consistently and very convincingly reduced the level of amyloid plaques in the brain.” According to the agency, a decrease in those plaques is “reasonably likely to predict important benefits to patients.”

Its expedited approval is subject to certain conditions. Biogen will be required to conduct post-approval studies in order to confirm the treatment’s expected clinical benefit. If the trials, known as phase 4 studies, do not show that aducanumab is effective, the FDA has stated that it may remove the drug from the market entirely.

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