FDA grants accelerated approval to first Alzheimer's drug since 2003 which comes with a “fair” $56,000 price tag

On Monday, the U.S. Food and Drug Administration (FDA) granted accelerated approved to Aducanuma, the first drug to treat Alzheimer's disease to be approved in nearly 20 years. The drug removes amyloid beta proteins from the brain and could slow down patients' cognitive decline. It is estimated that 6.2 million Americans have Alzheimer’s and that number is projected to more than double by 2050.

Alzheimer's is the sixth-leading cause of death in the U.S.

In a statement, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research said, “Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” adding that “currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

The drug’s manufacturer, Biogen Inc, said on Tuesday it expects to begin shipping the medication in two weeks.

Aducanumab – which will be sold under the brand name Aduhelm - is one of the medications used to treat patients in earlier stages of Alzheimer's and is designed to be administered as an intravenous infusion, likely at specialty infusion centers. Biogen said that over 900 infusion centers are ready to implement the treatment to patients.

Biogen CEO Michel Vounatsos said the sites include clinical trials centers with confirmed amyloid beta positive patients and sites with the infrastructure needed to diagnose and treat patients.

In clinical trials, Aducanumab showed a reduction in the plaques which is expected to lead to a reduction of decline of patients, including memory loss.

The drug will cost $56,000 per year of treatment. Biogen has received criticism over the high price tag, but in a Monday interview, Vounatsos told CNBC that the price of $56,000 per year for Aducanumab is “fair.”

Biogen has estimated that around 1.5 million Americans would be eligible for treatment with the drug.

For the FDA statement on granting approval, click here.

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