A sign with the company’s logo stands outside the headquarters of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana.
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The Food and Drug Administration on Tuesday approved Eli LillyAlzheimer’s drug donanemab, expanding limited treatment options for brain-destroying disease in US
The agency approved the treatment, which will be sold under the brand name Kisunla, for adults with early symptomatic Alzheimer’s disease, according to the company.
Almost 7 million Americans have the situation, the fifth leading cause of death for adults over age 65, according to the Alzheimer’s Association. By 2050, this group is projected to grow to nearly 13 million in the US
“This is real progress. Today’s approval gives people more choices and more opportunities to have more time,” said Joanne Pike, president and CEO of the Alzheimer’s Association. “Having multiple treatment options is the kind of progress we’ve all been waiting for – all of us who have been touched, even blinded, by this difficult and devastating disease.”
It’s a long-awaited win for Eli Lilly after donanemab faced hurdles on its way to market. The FDA rejected the drug’s approval last year due to insufficient data, then delayed it again in March. Last month, an advisory panel at the agency recommended the treatment for full approval, saying its benefits outweigh its risks.
A vial of Eli Lilly’s Alzheimer’s drug sold under the brand name Kisunla.
Source: Eli Lilly
Donanemab will compete head-to-head with another treatment from Biogen and its Japanese partner Eisai called Leqembi, which has been phased out in the US since winning approval last summer.
Donanemab and Leqembi are milestones in the treatment of Alzheimer’s disease after three decades of failed efforts to develop drugs that can fight the deadly disease. Both drugs are monoclonal antibodies that target toxic plaques in the brain called amyloid, a hallmark of Alzheimer’s disease, to slow the progression of the disease in patients in the early stages of the disease.
Eli Lilly’s drug slowed the progression of Alzheimer’s by 35 percent over 18 months compared with a placebo, according to a late-stage trial. Patients were able to stop their treatment and switch to placebo after six, 12 or 18 months after reaching certain targets for clearing amyloid plaque.
The drug, which is given through monthly infusions, will cost about $12,522 for a six-month course, $32,000 for 12 months and $48,696 for 18 months. Medicare coverage and reimbursement is available for eligible patients, Eli Lilly said.
No treatment is a cure. Drugs that target and clear amyloid plaque can also have significant safety risks, including swelling and bleeding in the brain that can be severe and even fatal in some cases.
Three patients who received 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 to reach the market after Leqembi and an ill-fated treatment from Biogen and Eisai called Aduhelm. The two companies recently abandoned this drug. The FDA has received criticism for its fast-track approval of Aduhelm in 2021, despite a negative recommendation from an advisory panel.
