Eli Lilly and Company has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.
The European Commission is expected to make a regulatory decision on donanemab in the coming months.
“This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across Europe,” said Patrik Jonsson, executive vice president and president of Lilly International.
“Donanemab has the potential to make a meaningful difference for people living with early symptomatic Alzheimer’s disease, and Lilly remains committed to advancing the science through ongoing clinical trials and programmes.”
Alzheimer’s disease currently affects as many as 6.9m 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 demonstrating that donanemab significantly slowed cognitive and functional decline and reduced the risk of progressing to the next clinical stage of disease, as well as 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.
Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the ApoE4 gene may be at higher risk of developing Alzheimer’s disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers.
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