FDA considering approval of first new Alzheimer’s drug in 20 years

For the first time in two decades the Food and Drug Administration is considering approving a new drug to treat Alzheimer’s disease.

The agency’s Peripheral and Central Nervous System Drugs Advisory Committee is meeting Friday to discuss an exploratory treatment for the progressive brain disorder that is administered through intravenous infusion for its early stages. The treatment, aducanumab, was developed by the biotechnology company Biogen and its Japanese partner Eisai, CNN reported.

“This is not a meeting that’s going to decide whether there is approval or not," Rudolph Tanzi, a Harvard professor of neurology and director of the Genetics and Aging Research Unit at Massachusetts General Hospital, told CNN. "This is an advisory committee that will give a recommendation to the FDA and then the FDA will ultimately decide if they’re going to approve it.”

“One would expect this advisory committee will have a lot of influence,” said Tanzi of the meeting, at which it is not clear whether or not the committee is intending on approving the treatment.

After the FDA considers the advisory committee’s recommendation, it’s possible that it may not move forward until 2021.

Still, Kevin Krudys, an FDA clinical analyst in neurology, wrote in a presentation sent to the committee, “the safety profile of aducanumab for the treatment of Alzheimer’s disease has been adequately characterized and is acceptable for the proposed indication.”

According to the New York Times, evidence indicates aducanumab can slow the progression of memory and thinking issues in people who have early or mild cognitive decline symptoms. It would not reverse or stop dementia, however.

There’s also a study showing uncertainty that the drug can efficiently treat the irreversible condition.

Alzheimer’s disease and other dementias affect 50 million people around the globe, according to the Alzheimer’s Association. Alzheimer’s is a form of dementia that affects memory, thinking and actions and symptoms eventually become severe and impede daily responsibilities.

No cure for the disease exists and currently, there are five FDA-approved prescription drugs to treat the symptoms. They include a class of drugs called cholinesterase inhibitors and memantine.