The Food and Drug Administration on Tuesday approved Eli Lilly's Alzheimer's drug donanemab, expanding the limited treatment options for the mind-wasting disease in the U.S.
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.
Nearly 7 million Americans have the condition, the fifth-leading cause of death for adults over 65, according to the Alzheimer's Association. By 2050, that group is projected to rise to almost 13 million in the U.S.
"This is real progress. Today's approval allows people more options and greater opportunity to have more time," said Joanne Pike, president and CEO of the Alzheimer's Association. "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."
It's a long-awaited win for Eli Lilly after donanemab faced obstacles in its path to market. The FDA rejected the drug's approval last year due to insufficient data, then surprisingly delayed it again in March. Last month, an advisory panel to the agency recommended the treatment for full approval, saying the benefits outweigh its risks.
Donanemab will compete head-to-head with another treatment from Biogen and its Japanese partner Eisai called Leqembi, which has gradually rolled out in the U.S. since it won approval last summer.
Donanemab and Leqembi are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. Both drugs are monoclonal antibodies that target toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, to slow the progression of the disease in patients at the early stages of it.
Eli Lilly's drug slowed Alzheimer's progression by 35% over 18 months compared with a placebo, according to a late-stage trial. Patients were able to end their treatment and switch to a placebo after six, 12 or 18 months after they hit certain goals for amyloid plaque clearance.
The drug, which is administered through monthly infusions, will cost an estimated $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.
Neither 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 took Eli Lilly's drug in a late-stage trial died from severe forms of those 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 therapy from Biogen and Eisai called Aduhelm. The two companies recently dropped that medicine. The FDA received criticism for its expedited approval of Aduhelm in 2021 despite a negative recommendation from an advisory panel.
