India Pharma Outlook Team | Monday, 28 July 2025
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are heterozygotes or non-carriers of apolipoprotein E e4 (ApoE4), according to a statement released by Eli Lilly and Company.
In the upcoming months, the European Commission is anticipated to issue a regulatory decision about donanemab. "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."
In Europe, 6.9 million people suffer from Alzheimer's disease at the moment; as the population ages, this number is predicted to nearly double by 2050. Within a year, about one-third of people with mild dementia or cognitive impairment from Alzheimer's disease advance to the next clinical stage of the illness.
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The TRAILBLAZER-ALZ 6 clinical trial, which assessed a modified titration dosing schedule, and the TRAILBLAZER-ALZ 2 clinical trial, which showed that donanemab significantly slowed cognitive and functional decline and decreased the risk of progressing to the next clinical stage of disease, were the main sources of the favorable opinion. While maintaining comparable levels of amyloid plaque removal and P-tau217 reduction, the modified titration schedule in the TRAILBLAZER-ALZ 6 study significantly reduced the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at 24 and 52 weeks when compared to the dosing schedule used in TRAILBLAZER-ALZ 2.
