Eli Lilly's Early Alzheimer's Drug Recommended For Approval By European Drug Regulator's Panel

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday recommending Eli Lilly and Co.’s (NYSE:LLY) donanemab for early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.

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Donanemab, a monthly infusion, is currently marketed as Kisunla in the U.S. and other countries.

In the U.S., Japan, China and many other countries, donanemab is approved for patients regardless of ApoE4 status.

Donanemab is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.

The European Commission is expected to make a regulatory decision on donanemab in the coming months.

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Alzheimer’s disease currently affects as many as 6.9 million people in Europe, with this figure expected to almost double by 2050 as aging populations continue to increase.

Approximately one-third of individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease progress to the next clinical stage of disease in one year.

The positive opinion was primarily based on clinical trial data from the TRAILBLAZER-ALZ 2 clinical trial, which demonstrated that donanemab significantly slowed cognitive and functional decline and reduced the risk of progressing to the next clinical stage of disease, and the TRAILBLAZER-ALZ 6 clinical trial, which evaluated a modified titration dosing schedule.

In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the dosing schedule used in TRAILBLAZER-ALZ 2 at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction

In July, the U.S. Food and Drug Administration approved a label update with a new recommended titration dosing schedule for Kisunla.

The FDA approved the drug in July 2024.

In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly reduced the incidence of ARIA-E compared to the original dosing schedule at 24 and 52 weeks, while achieving similar levels of amyloid plaque removal and P-tau217 reduction.

In other news, Sanofi SA (NASDAQ:SNY) agreed to acquire Vigil Neuroscience Inc. (NASDAQ:VIGL) for an approximately $470 million equity value. The acquisition strengthens Sanofi's neurology pipeline with VG-3927, an oral TREM2 agonist for Alzheimer's disease.

LLY Price Action: Eli Lilly stock is up 0.42% at $805.77 during the premarket session at publication on Friday.

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