FDA Approves Second Alzheimer’s Drug after Trial Shows it Can Slow Disease by 35%

The Federal Drug Administration gave the go-ahead to a second Alzheimer’s treatment Tuesday after a study suggested that it could slow the symptoms of the disease.

The drug, developed by Eli Lilly, is called donanemab and will be sold under the name “Kisunla” when it hits the market. The pharmaceutical giant has not set a release date.

Eli Lilly, which makes the anti-obesity drug Mounjaro, saw its shares rise slightly on the FDA approval.

The drug is for people at the early stages of Alzheimer’s and is administered by an infusion of a monoclonal antibody once every four weeks. Its cost will start at $12,522 for six months of treatment, and up to $48,696 for 18 months. Longer treatments involve more doses of the drug.

The pharma manufacturer said Medicare patients would be eligible for Kisunla treatment and reimbursement, after an agreement in October 2023 opened the way for some Alzheimer’s treatments to be covered.

Kisunla works by targeting amyloid plaques building up in the brain. The plaques’ presence is associated with the memory and cognition problems which are caused by Alzheimer’s. There has been scientific debate over whether the plaques cause the disease or are an effect of it, but the drug’s trials showed that it appeared to slow the progress of the symptoms while cutting the levels of plaques.

The final, or phase 3, study into the drug involved 1,736 people with the condition–which the Alzheimer’s Association estimated currently affects 6.9 million people in the U.S. In the study, the patients, who were between 60 and 85 and had joined the trial knowing they had the disease, were given either the drug or a placebo.

Researchers found that among those who received the real drug the progression of the disease was 35% slower than those who received the placebo. Doctors use a six-part test of memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care to assess the progress of the treatment.

But there were side effects: three patients died from severe side-effects of a condition called amyloid-related imaging abnormalities (ARIA). Overall, the FDA said that there is increased risk of brain swelling and bleeding among those taking the drug.

One of the people who took part in the trial, Pat Bishara, 79, from Carmel Indiana, told CNBC that she had been diagnosed in 2017 and sometimes had difficulty recalling people’s names but felt the treatment had helped. “I feel in my heart I wouldn’t be doing as well as I’m doing if I wouldn’t have been on something,” Bishara said.

The FDA’s decision to put the drug on the market means it will compete with Leqembi, which it approved last July and is jointly manufactured by Biogen and Japan’s Eisai. It targets a protein in the brain thought to be a cause of Alzheimer’s and was almost exactly as effective as Eli Lilly’s drug in its clinical trials.

Read more at The Daily Beast.