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FDA grants accelerated approval of new Alzheimer's treatment after trials show impact on cognitive decline

Posted at 8:12 AM, Jan 09, 2023
and last updated 2023-01-09 09:12:25-05

OMAHA, Neb. (KMTV) — A new treatment offering hope for Alzheimer's patients has received accelerated approval from the Food and Drug Administration.

Friday's announcement comes after drugmakers released results from a recent clinical trial that found the treatment slowed cognitive decline.

Some of the 1,800 people in the trial got the drug called Lecanemab while others got a placebo. They were then asked questions about memory, orientation and problem-solving.

The drug is seen as a breakthrough for people losing their memory to the disease. The dementia treatment consists of an intravenous infusion every two weeks and studies have shown it's more promising than the other few available treatments.

Experts say the drug seems to reduce the number of plaques in the brain of a person with Alzheimer's disease, but it comes with risks such as brain swelling and bleeding.

"We do know that Lecanemab has a low rate of causing macro hemorrhage, not necessarily fatal, but a low rate less than 1%," said Dr. Sharon Cohen, a behavioral neurologist with Toronto Memory Program.

The FDA says the drug's prescribing information will carry a warning about those risks.

Treatment is expected to cost $26,000 a year in the US. This is the second Alzheimer's treatment to receive an early green light in less than two years.

In 2021, the FDA approved the drug Aduhelm.

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