FDA approves Eli Lilly’s Alzheimer’s drug donanemab

Nearly 7 million Americans suffer from the disease, the fifth leading cause of death among adults over 65, according to the Alzheimer’s Association. By 2050, that 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 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 breakthrough we’ve all been waiting for, all of us who have been touched, or even blindsided, by this difficult and devastating disease.”

It’s a long-awaited victory for Eli Lilly, after donanemab hit hurdles on its path to market. The FDA rejected approval of the drug last year due to insufficient data, then surprisingly delayed it again in March. Last month, an agency advisory committee recommended full approval of the treatment, saying the benefits outweigh the risks.

Donanemab will compete directly with another treatment from Biogen and its Japanese partner Eisai called Leqembi, which has been gradually rolling out in the United States since its approval last summer.

Donanemab and leqembi are major advances in the treatment of Alzheimer’s disease, after three decades of unsuccessful efforts 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 disease, to slow the progression of the disease in patients in the early stages.

Eli Lilly’s drug slowed the progression of Alzheimer’s disease by 35% over 18 months compared with a placebo, according to a late-stage clinical trial. Patients were able to stop treatment and switch to a placebo after six, 12 or 18 months after reaching certain goals for clearing amyloid plaques.

The drug, given as a monthly infusion, 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 are 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 or even fatal in some cases.

Three patients who took 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 hit the market after Leqembi and an ill-fated treatment from Biogen and Eisai called Aduhelm. Both companies recently dropped that drug. The FDA has been criticized for fast-tracking Aduhelm’s approval into 2021 despite a negative recommendation from an advisory committee.