Eli Lilly's experimental Alzheimer's disease treatment, Kisunla — which slowed decline by up to 35% in clinical trials — has been approved by the FDA, after previously delaying its decision in March, the agency announced July 2.
Kisunla (donanemab) is approved to be given as an injection via infusion about every four weeks in patients experiencing mild cognitive impairment or mild dementia, according to the FDA.
In phase 3 clinical trials, Kisunla slowed cognitive and functional decline by up to 35% compared to a placebo, according to a news release from Eli Lilly. The drug was also found to reduce participants' risk of progressing further to the next stage of Alzheimer's.
The treatment is not meant to be ongoing and can be stopped when the plaques dissipate to a certain level.
"As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients," Howard Fillit, MD, cofounder and chief science officer at the Alzheimer's Drug Discovery Foundation said in the release.