Alzheimer's drug Leqembi is granted full FDA approval

by

Will Stribling

• Published on July 10, 2023 • Last modified on July 11, 2023 • Comments

This Oct. 7, 2003 file photo shows a closeup of a human brain affected by Alzheimer's disease, on display at the Museum of Neuroanatomy at the University at Buffalo in Buffalo, N.Y. On Friday, Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease. The Food and Drug Administration granted the approval Friday for patients in the early stages of Alzheimer's.
(AP Photo/David Duprey)

The Food and Drug Administration gave a drug for Alzheimer’s full approval on Thursday, the first time the agency has done so in two decades.

Will Stribling

Alzheimer's drug Leqembi given full FDA approval

The move by the FDA to approve the drug, Leqembi, set the stage for widespread use of the medication, which can modestly slow cognitive decline in the early stages of Alzheimer's. It could be a game changer for treatment of the disease in Mississippi, which has the highest rate of Alzheimer’s deaths in the nation

Dr. Juebin Huang works in the Department of Neurology at the University of Mississippi Medical Center and has been involved in Alzheimer's research since 2007. He's seen multiple drugs like Leqembi fail at the clinical trial stage and thinks this drug's approval will be a major boon for Alzheimer's research.

“I think it’s going to be a big boost for the field,” Huang said. “More researchers, more industries are going to look into this field and hopefully we have a lot more to come. Better medication and less side effects.”

Still, using the drug, which is administered as an intravenous infusion every two weeks, does come with significant safety risks. The FDA has placed its most urgent warning on the drug's label due to rare, but severe life-threatening events like brain swelling and bleeding.

Leqembi cannot repair cognitive damage or prevent the disease from getting worse, but it can slow it down. Data from a large clinical trial showed it slowed cognitive decline by around five months over an 18 month period for people in the early stages of Alzheimer's. While it's not a cure, Huang says it can offer patients something they want desperately: more time.

“It’s still significant,” Huang said. “Think about someone who has five more months of good times… enjoying the things they are doing. It means a lot for the patient and family.”

Medicare will cover 80% of the drugs high cost, but this will still leave patients utilizing the treatment on the hook for thousands of dollars in co-pays each year.