Eli Lilly & Co.’s Alzheimer’s disease drug Kisunla failed to get the backing of European regulators, who said its benefits don’t outweigh the risk of potentially fatal bleeding in the brain. Read More
Eli Lilly & Co.’s Alzheimer’s disease drug Kisunla failed to get the backing of European regulators, who said its benefits don’t outweigh the risk of potentially fatal bleeding in the brain. Eli Lilly had sought to get the drug cleared for early Alzheimer’s disease. The recommendation by the European Medicines Agency’s drug advisory committee is
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Eli Lilly & Co.’s Alzheimer’s disease drug Kisunla failed to get the backing of European regulators, who said its benefits don’t outweigh the risk of potentially fatal bleeding in the brain.
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Eli Lilly had sought to get the drug cleared for early Alzheimer’s disease. The recommendation by the European Medicines Agency’s drug advisory committee is pending a final decision by the European Commission. Lilly said it will seek another review, calling the opinion “disappointing” in a statement.
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The thumbs-down is a setback for Lilly, which is competing with Eisai Co. and partner Biogen Inc. in a global market for Alzheimer’s treatments that could surge to $13 billion by 2030 from about $250 million last year, according to Bloomberg Intelligence.
The committee cited a side effect known as Aria, which involves swelling and the potential for bleeding in the brain. The committee noted three deaths of people treated with the medicine.
Lilly said it still hopes to bring its drug to European patients, adding that it’s confident in its safety and effectiveness.
The shares were down 0.6% in light trading before U.S. markets opened.
The committee has backed a similar medicine from Eisai and Biogen, though its use was limited to patients at lower risk for dangerous side effects such as brain swelling. That drug, Leqembi, also had a rocky path in Europe: after an initial advisory committee rejection, the panel supported the drug for a limited patient group. It confirmed that decision earlier this year after further safety review.
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Both Leqembi and Kisunla are infusions that remove toxic amyloid from brain, though they only modestly slow the disease. They are approved in the U.S. for people with early-stage Alzheimer’s — a minority of the total patient population.
Lilly previously secured approval for Kisunla in the U.S., Japan and the U.K. It has a potential convenience advantage because it’s infused monthly, while Leqembi is given every other week.
— With assistance from Sonja Wind.
For more health news and content around diseases, conditions, wellness, healthy living, drugs, treatments and more, head to Healthing.ca – a member of the Postmedia Network.
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