Eli Lilly Alzheimer’s Drug Kisunla Fails To Get EU Backing
Lilly said it will seek another review, calling the opinion “disappointing” in a statement.
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 review committee is pending a final decision by the European Commission.
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.
Eli Lilly has 15 days from the date of the opinion, issued yesterday, to ask for another review.
The shares were down 1.3% in light trading before US markets opened.
