Eli Lilly has announced that its Alzheimer’s treatment drug has slowed cognitive decline and functional decline in a study, giving millions of patients and their families “real hope that they will have a brighter future fighting this disease.”
The pharmaceutical company on Wednesday shared the results from its TRAILBLAZER-ALZ2 Phase 3 clinical trial of donanemab for the treatment of early symptomatic Alzheimer’s disease.
The drug significantly slowed cognitive and functional decline in patients. Trial participants who received the drug showed a significant reduction in amyloid plaque (a protein associated with Alzheimer’s), a slowing of cognitive decline by 35%, and slowing of functional decline by 40% over 18 months.
These are the “strongest phase 3 data for an Alzheimer’s treatment to date,” according to the Alzheimer’s Association chief science officer.
“This further underscores the inflection point we are at for the Alzheimer’s field,” added chief science officer Maria Carrillo. “The progress we’ve seen in this class of treatments, as well as the diversification of potential new therapies over the past few years, provides hope to those impacted by this devastating disease.”
Eli Lilly reported that nearly half (47%) of the study participants taking donanemab had no decline of cognition and function for one year (compared to 29% on placebo).
“Today’s announcement is good news,” said Global Alzheimer’s Platform Foundation President John Dwyer. “After waiting nearly 20 years for a new treatment for Alzheimer’s, Alzheimer’s patients and their doctors are on the cusp of having another disease-modifying therapy to treat their condition.
“Millions of people with Alzheimer’s and their families have real hope that they will have a brighter future fighting this disease,” he added.
Dwyer urged the Food and Drug Administration to review this therapy and quickly determine whether it is safe and effective.
For people in the earliest stages of Alzheimer’s, these results suggest donanemab will significantly change the course of the disease. The study signaled that donanemab gives people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions.
“We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial,” said Daniel Skovronsky, Lilly’s chief scientific and medical officer. “This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”
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