Eli Lilly’s Alzheimer’s drug not recommended by top European regulator

Indiana-based pharmaceutical company Eli Lilly is part of the race to slow or prevent Alzheimer's disease worldwide. One of its drugs was recently approved in the United States. But the European Medicines Agency recommended against the approval of the drug on Thursday.

Kisunla, also known as donanemab, is a monthly Alzhemier’s injection produced by Eli Lilly that treats mild cognitive impairment and mild dementia stage due to early symptomatic Alzheimer's disease.

Company research shows it slowed cognitive decline by up to 35%, and was approved for use in the U.S. last year.

But the Committee for Medicinal Product for Human Use, part of the European Medicines Agency, said the benefits of the treatment don’t outweigh the potential side effects, like fatal brain swelling.

The clinical trial for Kisunla included over 1,700 people located in eight countries. Of that group, three people died, potentially from the treatment.

“In reaching its conclusion, the Agency acknowledged the unmet medical need for treatment of Alzheimer’s disease and took into consideration the views of patients and healthcare professionals who shared their needs and experiences related to living with or treating the condition,” the CHMP wrote in an overview of its opinion.

Ilya Yuffa, executive vice president and president of Lilly International wrote in a press release that the company remains “confident in the safety and effectiveness of the treatment,” which has also been approved in Great Britain, Japan and China.

“Europeans living with early symptomatic Alzheimer’s disease and their loved ones urgently need additional treatment options,” Yuffa said. “Today’s disappointing CHMP opinion means they must keep waiting.”

Roughly 7 million Europeans live with Alzheimer’s disease, with numbers estimated to increase to 14 million by 2030, according to the European Brain Council.

In the U.S., an estimated 6.7 million Americans aged 65 and older had Alzheimer's dementia in 2023, and research from the National Library of Medicine shows the number could increase to 13.8 million by 2060.

Two years ago the U.S. approved Leqembi, an Alzheimer’s treatment developed by Biogen Inc. in Cambridge, Mass. and Eisai Co in Japan. It was initially rejected by CHMP in July 2024. But after a re-examination process, the committee later reversed its statement and recommended it last November.

Joanne Pike, CEO and president of the Alzheimer’s Association based in Chicago, Ill., hopes the EMA’s committee will also reconsider its opinion on Kisunla.

“As the EMA did when they first delayed approval for another treatment, Leqembi, we expect the EMA will quickly reverse this decision,” Pike said. “It is a shame that the EMA is delaying access to a treatment that benefits people in the earliest stages.”

Lilly International hopes a re-examination process will prompt the European Medicines Agency to reconsider its opinion.

The European Commission, an agency in charge of policy and international aid distribution, will provide the ultimate decision within 67 days of CHMP’s opinion.

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