A panel of independent advisors to the U.S. Food and Drug Administration (FDA) have recommended Eli Lilly’s (LLY) new Alzheimer’s drug called “Donanemab,” clearing the way for the medication to receive regulatory approval later this year.
The FDA usually follows recommendations from its advisory panels but is not required to do so.
If approved, Donanemab would be the second Alzheimer’s drug of its kind that’s available in the U.S. along with a treatment called “Leqembi” from Biogen (BIIB).
An approval of Eli Lilly’s drug would expand the treatment options for the more than six million Americans who have Alzheimer’s, the fifth-leading cause of death for people over age 65.
Donanemab will also give Eli Lilly another potential blockbuster drug at a time when it is seeing brisk sales of its Zepbound weight loss medication.
In a unanimous vote, 11 members on the independent panel said available data on the Alzheimer’s drug shows that it is effective at treating patients in the early stages of the disease.
In a second vote, advisors unanimously said that the benefits of Donanemab outweigh its risks.
In a written statement, Eli Lilly said that it is pleased with the panel’s recommendation and looks forward to bringing the treatment to patients across the U.S.
Donanemab is viewed by many in the medical profession as a milestone in the treatment of Alzheimer’s after three decades of failed efforts to develop medicines that can fight the disease.
The drug is a monoclonal antibody that targets amyloid plaque in the brain, considered the main cause of Alzheimer’s, and slows progression of the disease at the early stages.
Eli Lilly’s phase three clinical trial of more than 1,700 patients found that Donanemab slowed the progression of Alzheimer’s by 29% compared to a placebo after 18 months.
The stock of Eli Lilly is up 3% on news of the panel’s recommendation of Donanemab. In the past 12 months, the company’s share price has gained 94% to trade at $865 U.S.
