A sign with the company logo stands in front of the headquarters of Eli Lilly and Company in Indianapolis, Indiana on March 17, 2024.
Scott Olson |
The Food and Drug Administration approved on Tuesday Eli LillyThe Alzheimer's drug Donanemab expands the limited treatment options for the mental illness in the USA
According to the company, the agency has approved the treatment, sold under the brand name Kisunla, for adults with Alzheimer's disease in the early stages of symptoms.
According to the Alzheimer's Association, nearly 7 million Americans suffer from the disease, the fifth leading cause of death among adults over 65. By 2050, this group is expected to grow to nearly 13 million in the United States.
“This is real progress. Today's approval gives people more options and the opportunity to have more time,” said Joanne Pike, president and CEO of the Alzheimer's Association. “Having multiple treatment options is the progress we've all been waiting for – all of us who have been affected, if not blindsided, by this difficult and devastating disease.”
For Eli Lilly, it is a long-awaited victory after donanemab encountered obstacles on its way to market. The FDA rejected approval of the drug last year due to insufficient data and then unexpectedly postponed it again in March. Last month, an advisory panel to the agency recommended full approval of the treatment, saying the benefits outweighed the risks.
An ampoule of Eli Lilly's Alzheimer's drug, sold under the brand name Kisunla.
Source: Eli Lilly
Donanemab will compete directly with another drug from Biogen and its Japanese partner Eisai called Leqembi, which has been gradually introduced in the United States since its approval last summer.
Donanemab and Leqembi are milestones in the treatment of Alzheimer's disease after three decades of failing to develop drugs to treat the deadly disease. Both drugs are monoclonal antibodies that target toxic plaques in the brain called amyloid, a hallmark of Alzheimer's disease, and are designed to slow the progression of the disease in early-stage patients.
According to an advanced-stage study, Eli Lilly's drug slowed the progression of Alzheimer's disease by 35% over 18 months compared with a placebo. Patients could stop their treatment and switch to a placebo after six, 12 or 18 months after they met certain goals for clearing amyloid plaques.
More health reports from CNBC
The drug, which is administered monthly in the form of infusions, is estimated to cost $12,522 for six months of treatment, $32,000 for 12 months of treatment and $48,696 for 18 months of treatment. Eligible patients can have the cost covered by their health insurance (Medicare), Eli Lilly said.
Neither treatment is a cure. Drugs that specifically remove amyloid plaques can also carry significant safety risks, including swelling and bleeding in the brain, which can be serious and, in some cases, fatal.
Three patients taking Eli Lilly's drug in a late-stage trial died from severe forms of these side effects, called amyloid-related imaging abnormalities, or ARIA.
Eli Lilly's drug is now the third of its kind on the market, after Leqembi and an ill-fated drug from Biogen and Eisai called Aduhelm. The two companies recently pulled the drug from the market. The FDA has been criticized for its accelerated approval of Aduhelm in 2021 despite a negative recommendation from an advisory panel.
