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EU regulator backs Eli Lilly’s Alzheimer’s drug after initial rejection
EUROPE, JUL 25 – The European Medicines Agency reversed its initial rejection to recommend donanemab for early Alzheimer's in patients with specific genetic profiles under strict safety protocols.
- On July 25, 2025 in Indianapolis, the CHMP recommended donanemab for early Alzheimer’s, referring it to the European Commission for final approval.
- In late March, EMA evaluators noted that the initial safety review found risks did not outweigh benefits due to potential deadly brain swelling and bleeding, while TRAILBLAZER-ALZ 6 study showed a modified schedule lowered ARIA-E incidence while maintaining efficacy.
- Donanemab is marketed as Kisunla in the United States and at least 13 other countries including Japan, China, the UK, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico and Australia.
- Following the recommendation, donanemab can be offered to specific Alzheimer’s patients in Europe, and Eli Lilly shares rose 1.2%.
- The European Commission is expected to decide in the coming months, potentially impacting 6.9 million patients in Europe, with donanemab offering a treatment innovation.
14 Articles
14 Articles
The European Medicines Agency has given the green light for a new Alzheimer's drug. It is expected to delay the course of the disease by up to half a year in the early phase – if it is administered early enough. However, only ten percent of those affected are eligible for therapy.
EU regulator backs Eli Lilly’s Alzheimer’s drug after initial rejection
(Reuters) -Eli Lilly said on Friday that the European Medicines Agency (EMA) has recommended approval of its drug Kisunla for certain patients with early Alzheimer’s disease, reversing an initial decision from four months ago. In March, the EMA said the treatment’s ability to slow cognitive decline was not significant enough to outweigh the risk of serious brain swelling in patients. Shares of the Indianapolis-based company were up 1.2% in morni…
Donanemab, however, cannot be applied to all those affected by the disease.
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