The medicine, donanemab, achieved every trial target. According to Lilly, in 1,182 patients with early-stage Alzheimer’s who had scans showing amyloid protein deposits in the brain and intermediate levels of tau protein, it reduced the progression of the illness by 35% to 36% in comparison to a placebo.
The 552 additional study participants had high tau levels, which indicated a lower likelihood that they would benefit from the therapy.
Combining the two groups revealed that donanemab slowed the advancement of Alzheimer’s disease by 22% using a Lilly-developed scale to assess cognition and daily living, and by 29% based on a more widely used scale of dementia progression.
According to Maria Carrillo, the Alzheimer’s Association’s chief science officer, “these are the strongest phase 3 data for an Alzheimer’s treatment to date.”
The Leqembi drug developed by Eisai Co Ltd and Biogen Inc. lowered the rate of cognitive loss in individuals with early Alzheimer’s by 27%, according to study results published last year.
In premarket trade on Wednesday, rival Biogen slid 2.5% to $301.50 while Eli Lilly’s shares increased 5.6% to $427.05.
According to Lilly, 6.1% of those receiving donanemab experienced symptoms, and 24% of participants experienced brain swelling, a documented side effect of this class of medication. Donanemab users (31.4%) and placebo users (13.6%) both experienced brain hemorrhage.
The medicine caused brain enlargement in roughly 13% of research participants in the Leqembi Phase 3 trial.
In the donanemab research, Lilly reported a 1.6% incidence of major brain swelling, which included two deaths directly related to the condition and one death following a serious brain swelling episode.
“Donanemab is the new gold standard for Alzheimer’s effectiveness. To reduce safety hazards, neurologists must receive education, according to research note by Citi analyst Andrew Baum.
Donanemab is being used in a research to prevent Alzheimer’s disease in people who are presymptomatic, and Dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute, said he was “very excited” about the results. However, there is a risk that needs to be taken into account. Clearly, there were benefits.
By the end of June, Lilly said it will petition for customary U.S. approval, and shortly after that, it would do the same with regulators in other nations.
“There are risks in medicine, but I think when you look at these results in the context of a fatal life-threatening disease, (they) are quite meaningful,” Lilly Neuroscience CEO Anne White said in a Reuters interview.
Donanemab was administered intravenously on a monthly basis to study participants. Following brain scans revealed that the amyloid had been eliminated, the treatment was discontinued, and the volunteers were switched to the study’s placebo group. At 12 months, the company reported that half of the trial subjects showed no signs of amyloid plaques.
As opposed to 29% of the placebo group, 47% of donanemab patients in the 18-month trial showed no disease progression at 12 months.
Following the U.S. approval of two related drugs created by partners Eisai and Biogen — Leqembi and Aduhelm — which failed to gain traction with physicians or insurers after showing scant evidence of slowing cognitive decline, Lilly’s medication is likely to become the third in its class to hit the market.
Based on their capacity to eliminate amyloid plaques, both were accepted under the FDA’s accelerated review procedure.
Leqembi is currently going through the FDA’s routine review procedure, and a decision is anticipated on July 6.
The Alzheimer’s Association estimates that more than 6 million Americans currently have Alzheimer’s disease, and that figure will reach about 13 million by 2050.
