The Food and Drug Administration (FDA) on Tuesday approved Eli Lilly’s Alzheimer’s drug, the company announced, paving the way for another market entry of a new class of drugs that moderately slows the disease’s progression.
The agency last month held an advisory panel meeting to examine 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 application for donanemab approval to the FDA last year and was expected to get the green light in early 2024.
The FDA’s independent consultants unanimously supported the approval recommendation.
Donanemab, now marketed as Kisunla, is a monoclonal antibody that targets a brain plaque called amyloid. It is intended for the treatment of early-stage diseases and is administered monthly by intravenous infusion.
The drug will be available in the coming weeks, Lilly said.
According to Lilly, donanemab slowed the progression of Alzheimer’s disease by 35 percent compared to placebo treatment in an 18-month clinical trial involving 1,700 patients with early-stage disease. In practical terms, this translated into delaying progression by about four months.
Serious risks were identified in the trial, raising concerns that the risk outweighed the benefit. Three people died after developing severe brain bleeding or swelling.
Anti-amyloid drugs can significantly reduce levels of a sticky plaque in the brain called beta-amyloid, 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 this number is expected to increase 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 medicine.
“This is real progress. Today’s approval allows people more options and greater opportunities to have more time. Having multiple treatment options is the kind of breakthrough we have all been waiting for – all of us who have been touched, even taken by surprise, by this difficult and devastating disease,” said Joanne Pike, president and CEO of the Alzheimer’s Association, in a statement. .
Donanemab is the third amyloid-targeting Alzheimer’s drug to get the green light from the FDA since 2021. Biogen and Eisai jointly developed Aduhelm and Leqembi, although Aduhelm was plagued by controversy from the start and was discontinued in January.
Unlike Leqembi, donanemab use can be stopped after amyloid plaque has been removed to minimal levels, which Lilly says can result in lower treatment costs and fewer infusions.
The price for each bottle of Kisunla is $695.65, Lilly said, which equates to $32,000 for one year. That’s more than Leqembi, which costs patients about $26,500 a year. But patients don’t stop taking Leqembi.
The actual cost will depend on how long patients receive the treatment, although Lilly noted that Medicare Part B will cover and provide some reimbursement – patients will be responsible for a 20% coinsurance after meeting their deductible.
Updated at 4:06 p.m.
This story originally appeared on thehill.com read the full story
