Alzheimer’s Drug Donanemab Wins Approval From FDA Advisory Board

An experimental Alzheimer’s drug has received unanimous approval from a Food and Drug Administration advisory panel.

The drug, called donanemab, is made by Eli Lilly and has been shown to have benefits of slowing the progression of cognitive decline in people with early stages of Alzheimer’s.

The drug is given as an infusion and works by helping to remove the amyloid plaque buildups thought to cause Alzheimer’s.

Like some other drugs used to treat Alzheimer’s donanemab has side effects that include brain swelling and bleeding. Three people on the drug during a 76-week study.

People taking the drug saw their cognitive decline delayed by 4.5 to 7.5 months, according to Eli Lilly, as noted in recent reporting from the New York Times. Ultimately those benefits outweighed the risks of taking it, and the drug won approval from the FDA advisory committee.

The drug was previously expected to be approved by the FDA in March, but first had to receive approval from the advisory committee. The advisory committee that approved donanemab is among multiple under the FDA that inform the regulatory body’s decisions. The U.S. federal agency typically follows the committees’ recommendations, though not always.

The drug’s approval process was similar to that of Leqembi, a drug from  Eisai and Biogen that has similar side effects to donanemab. Biogen was also behind Aduhelm, a drug with a controversial history that the maker eventually discontinued.

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