Eli Lilly's (LLY.US) Alzheimer's drug Kisunla receives EU support and gets approved for use in specific patient populations.

Eli Company's (LLY.US) Alzheimer's drug Kisunla has received support from the European Union regulatory agency, and has been approved for use in specific patient groups. This development may pave the way for it to become the second drug in Europe to target the most common cause of delaying Alzheimer's disease in the elderly. The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approving Kisunla for patients carrying specific gene mutations with a copy number of 0 or 1. This gene mutation may increase the risk of amyloid-related imaging abnormalities (ARIA) - a potentially fatal brain swelling disease. In the United States, the approved patient population for this drug is broader. The EU had previously approved a similar drug, Leqembi, developed by Eisai and Biogen, but its use is limited to patients with a lower risk of brain swelling. In pre-market trading on Friday, Eli's stock price rose slightly by 0.5%. As of the close of trading on Thursday, the stock had fallen by about 2% over the past 12 months. The European Medicines Agency stated that Kisunla can slow down the progression of cognitive and functional impairment associated with Alzheimer's disease, with the most common side effects being ARIA and headache. The European Commission still needs to provide final confirmation for the approval of Kisunla before the drug can be used in the EU. This positive opinion overturns the previous negative conclusion, similar to the situation when Leqembi was approved in the EU. Eli was able to achieve this reversal by submitting new analysis data, collecting feedback from patients and healthcare professionals, proposing new dosing regimens, and additional measures to reduce the risk of ARIA. This move has pushed Eli and Eisai's competition in the Alzheimer's drug market to a new stage. The field has long been plagued by setbacks, safety issues, and low market acceptance, causing Bloomberg Intelligence to halve its projected market size to $60 billion by 2030. According to Bloomberg's forecast, Kisunla's annual single drug sales could reach around $20 billion by then. Both drugs clear toxic amyloid proteins from the brain through infusion, moderately delaying the progression of the disease, but are only approved for early-stage Alzheimer's patients - a relatively small percentage of the total patient population. Additionally, both drugs have side effects, including potential risks of brain swelling and bleeding. Previously, Eli had obtained market approval for Kisunla in the United States, Japan, and the United Kingdom. Compared to the biweekly dosing of Leqembi, Kisunla's monthly infusion may have a convenience advantage.