LY.US (LLY.US) Alzheimer's drug is not approved by the European Union, safety issues are a major obstacle

The Zhitong Finance App learned that Kisunla, an Alzheimer's drug launched by US pharmaceutical giant LLY.US (LLY.US), failed to obtain official approval from European regulators, and regulators believe that the benefits of the drug cannot offset the risk that it may cause fatal brain hemorrhage.

Eli Lilly had previously sought official approval for the drug for early-stage Alzheimer's disease. However, this recommendation from the European Medicines Agency (EMA) Drug Review Committee, the EU's official drug regulator, still awaits a final decision by the European Commission.

According to information, the review committee indicated that the drug has a major side effect known as ARIA (amyloid-related imaging abnormalities). This side effect involves brain swelling and a potential risk of major bleeding. The Commission specifically mentioned the deaths of three patients treated with the drug.

According to the regulatory opinion issued yesterday, Eli Lilly has 15 days to request a review from the European Medicines Agency.

In trading before the opening of the US market, Eli Lilly's stock price fell by about 1.3%, and the trading volume was relatively light.

The Alzheimer's drug Kisunla (generic name donanemab-azbt) introduced by Eli Lilly is an anti-Abeta monoclonal antibody therapy based on the beta amyloid (Aβ) hypothesis. The basic principle is that kiSunla can bind specifically to specific subtypes (such as N3PG) of beta amyloid plaques deposited in the brain, thereby promoting the removal of these plaques. Numerous studies have shown that Abeta plaques play a key role in the pathogenesis of Alzheimer's disease. When plaques accumulate to a certain extent, they trigger a series of downstream pathological events (such as tau protein pathology, neuroinflammation, etc.), leading to neuronal damage and cognitive decline.

ARIA mainly manifests as temporary swelling (ARIA-E) or microhemorrhage (ARIA-H) in the brain. This is because monoclonal antibodies may cause rapid release or redistribution of Abeta in the blood vessel wall during plaque removal, which in turn causes fluid balance disorders inside and outside blood vessels. In most cases, ARIA is asymptomatic, but in some patients, headache, dizziness, and in severe cases, it may be life-threatening.

European regulators believe that although Kisunla has shown some efficacy in removing Abeta plaques when treating patients with early-stage Alzheimer's disease, the risk of ARIA caused by it (for example, the high incidence of ARIA of 36.8% observed in clinical trials and 1.6% of serious to life-threatening ARIA events, and higher risk in some high-risk subgroups) may not offset safety risks.