Eli Lilly Alzheimer's drug approved by US FDA

The U.S. Food and Drug Administration on Tuesday approved Eli Lillys (LLY.N), opens new tab treatment for early Alzheimers, making it the second therapy for slowing progression of the brain-wasting disease that will be available to U.S. patients.

The approval for donanemab, to be sold under the brand name Kisunla, followed the recommendations of the agencys outside experts, who unanimously backed its use in patients with early Alzheimers disease, saying the benefits of the drug outweighed its risks.

“This is real progress," said Joanne Pike 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.”

Like Eisai (4523.T), opens new tab and Biogens (BIIB.O), opens new tab rival drug Leqembi, which was approved a year ago, donanemab is designed to clear an Alzheimers-related protein called beta amyloid from the brain.

A key differentiating factor for donanemab is the drugs finite dosing, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques.

Lilly priced its drug at $695.65 per vial, or about $32,000 for 12-months of treatment consisting of 13 infusions. Thats slightly higher than Eisais Leqembi, which costs $26,500 a year.

BMO analyst Evan Seigerman said the price reflects the fact that patients can stop treatment versus chronic treatment with Leqembi.