A sign with the company logo stands outside the Eli Lilly and Company headquarters on March 17, 2024 in Indianapolis, Indiana.
Scott Olson | Getty Images
The Food and Drug Administration on Tuesday approved Eli LillyAlzheimer's drug donanemab expands limited treatment options for the mind-destroying disease in the US
According to the company, the agency has approved the treatment. The treatment will be marketed under the brand name Kisunla and is intended for adults with early symptomatic Alzheimer's disease.
Almost 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 expected to rise to nearly 13 million in the U.S.
It’s a long-awaited victory for Eli Lilly after donanemab hit bumps on its way to market. The FDA rejected approval of the drug last year, citing insufficient data, and then surprisingly delayed it again in March. Earlier this month, an advisory panel to the agency recommended the treatment for full approval, saying its benefits outweigh its risks.
A bottle of Eli Lilly's Alzheimer's drug, sold under the brand name Kisunla.
Source: Eli Lilly
Donanemab will compete directly with another treatment from Biogen and its Japanese partner Eisai, called Leqembi, which has been gradually rolling out in the U.S. since it was approved last summer.
Donanemab and Leqembi are milestones in Alzheimer’s treatment after three decades of failed attempts to develop drugs to combat the deadly 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 early-stage patients.
According to a late-stage study, Eli Lilly’s drug slowed Alzheimer’s progression by 35 percent 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.
The drug, which is administered through monthly infusions, is estimated to cost $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 remove amyloid plaque can also carry significant safety risks, including swelling and bleeding in the brain that can be serious and, in some cases, fatal.
Three patients taking Eli Lilly's drug in a late-stage study died from severe forms of these side effects, called amyloid-related imaging abnormalities (ARIA).
Eli Lilly’s drug is now the third of its kind to come to market, following Leqembi and an ill-fated therapy from Biogen and Eisai called Aduhelm. The two companies recently dropped that drug. The FDA has faced criticism for accelerating Aduhelm’s approval in 2021 despite a negative recommendation from an advisory panel.
