FDA approves Lilly's new Alzheimer's drug after delay

The Food and Drug Administration (FDA) on Tuesday approved Eli Lilly’s Alzheimer’s drug, the company announced, clearing the way for another entry into the market of a new class of drugs that moderately slows the disease’s progression. 

The agency last month held an advisory panel meeting to scrutinize the safety and effectiveness of the drug, called donanemab, after delaying approval in March.  

The decision to require a panel meeting came as a surprise to the company, which submitted its traditional approval application of donanemab to the FDA last year and anticipated getting the green light by early 2024.   

FDA’s independent advisers unanimously backed recommending approval.  

Donanemab, now marketed as Kisunla, is a monoclonal antibody that targets a brain plaque called amyloid. It’s intended to treat early-stage disease and is administered monthly by intravenous infusion.  

The drug will be available in the coming weeks, Lilly said.  

According to Lilly, donanemab slowed Alzheimer’s disease progression by 35 percent relative to placebo treatment, in an 18-month clinical trial that enrolled 1,700 patients with early-stage disease. In practical terms, that translated to delaying progression by about four months.   

There were serious risks identified in the trial, raising concerns that the risk outweighed the benefit. Three people died after developing serious brain bleeding or swelling.   

Anti-amyloid drugs can significantly reduce the levels of a sticky plaque in the brain called amyloid beta, but questions remain about the clinical significance and degree of benefit.  

More than 6 million people in the United States are diagnosed with Alzheimer’s, and that number is expected to rise as the population ages. There is no cure, but there are about 1 million people with early-stage disease who could benefit most from the drug.  

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time. 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," Joanne Pike, president and CEO of the Alzheimer's Association said in a statement.

Donanemab is the third amyloid-targeting Alzheimer’s drug to get the green light from FDA since 2021. Biogen and Eisai jointly developed Aduhelm and Leqembi, though Aduhelm was plagued by controversy from the start and was discontinued in January.   

Unlike Leqembi, donanemab use can be stopped after amyloid plaque is removed to minimal levels, which Lilly said can result in lower treatment costs and fewer infusions. 

The price of each vial of Kisunla is $695.65 Lilly said, which equates to $32,000 for a year. That's more than Leqembi, which costs patients an estimated $26,500 a year. But patients don't stop taking Leqembi.

The actual cost will depend on how long patients take the treatment, though Lilly noted Medicare Part B will cover and provide some reimbursement—patients will be responsible for a 20 percent coinsurance after meeting their deductible.  

Updated at 4:06 p.m.