The US Food and Drug Administration (FDA) approved a second monoclonal antibody treatment for for early Alzheimer’s on Tuesday. Eli Lilly’s Kisunla (donanemab), which has proven to slow the disease by a few months, follows the approval of Leqembi (lecanemab) last year.
Also last year, the FDA voted against accelerated approval for Kisunla, which is for those with mild cognitive impairment and in the mild dementia stage of Alzheimer’s disease.The medication targets the buildup of amyloid proteins in the brain, which are indicative of the disease. Anyone approved to take it must have confirmed amyloid beta pathology in their brain.
The Alzheimer’s Association immediately praised the move by the FDA.
“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” Joanne Pike, DrPH, Alzheimer’s Association president and CEO, said in a statement Tuesday. “Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”
The FDA’s decision comes after an independent panel gave a thumbs-up to the FDA to approve the medication in June. In an 18-month study, people on the drug had 22% slower memory and cognitive ability loss compared to those on a placebo. The drug can delay the progression of the disease by about seven months.
Side effects can include hives or trouble breathing, but the drug also comes with a warning for potentially fatal brain swelling — amyloid-related imaging abnormalities (ARIA) — a serious side effect facing those on Leqembi as well.
In the study, 20% of people experienced microbleeds, which was a little higher than those in the Leqembi trial. AP noted that the drugs were tested in different types of patients, making it challenging to compare safety accurately.
Monthly intravenous infusions of the drug will cost about $32,000 for the year, which is higher than Leqembi’s $26,500 price tag.
According to FDA prescribing information, doctors can advise that patients stop the drug after seeing less plaque in the brain.
“I’m thrilled to have different options to help my patients,” Suzanne Schindler, a neurologist at Washington University in St. Louis, told AP. “It’s been difficult as a dementia specialist — I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die.”
