Eli Lilly’s Alzheimer’s disease (AD) drug donanemab has been recommended by the European Medicines Agency’s human medicines committee to treat adults with early symptomatic cases of the neurodegenerative disorder.
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the drug be approved to treat patients with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.
Up to 6.9 million people in Europe are affected by AD, which progressively destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Donanemab, approved under the brand name Kisunla in countries including the US and Great Britain, is administered as a monthly intravenous infusion and designed to help the body remove the excessive buildup of amyloid plaques in the brain associated with AD.
Patrik Jonsson, executive vice president and president of Lilly International, said the positive opinion “marks a significant milestone in [the company’s] efforts to bring donanemab to eligible patients across Europe”.
“Donanemab has the potential to make a meaningful difference for people living with early symptomatic AD, and Lilly remains committed to advancing the science through ongoing clinical trials and programmes,” Jonsson added.
The CHMP’s decision on the drug was primarily based on results from the TRAILBLAZER-ALZ 2 trial, in which donanemab significantly slowed cognitive and functional decline, as well as lowered the risk of progressing to the next clinical stage of disease.
Data from the TRAILBLAZER-ALZ 6 study, in which a modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with oedema/effusion, also supported the positive opinion.
The European Commission (EC) will now review the CHMP’s recommendation as it makes a final decision on donanemab in this indication.
Welcoming the recommendation, Jean Georges, executive director of Alzheimer Europe, said: “The positive opinion on donanemab marks an important step forward, offering a second approved disease-modifying therapy for early AD in Europe and expanding treatment options through its distinct dosing and stopping regimen.
“We hope that this opinion will lead to a prompt marketing authorisation by the EC, so that discussions on access, pricing and reimbursement can proceed at national level.”