Lilly's Alzheimer's Drug Kisunla Gains EU Backing for Use in Specific Patient Population

SmartCom APP learned that Kisunla, an Alzheimer's drug developed by Eli Lilly and Company (LLY.US), has gained support from EU regulatory authorities and has been approved for use in specific patient groups. This progress may pave the way for it to become the second drug in Europe to slow the most common cause of dementia.

The European Medicines Agency (EMA)’s drug advisory committee has recommended the approval of Kisunla for patients with 0 or 1 copy of a specific genetic variant. This genetic variation may increase the risk of "Amyloid-Related Imaging Abnormalities (ARIA)" — a potentially fatal brain swelling condition. In the United States, the approved patient population for this drug is broader. Previously, the EU had already approved Leqembi, a similar drug jointly developed by Eisai and Biogen, but its use was also restricted to patients at lower risk of brain swelling.

Eli Lilly's shares rose slightly by 0.5% in pre-market trading on Friday. As of Thursday's close, the stock had fallen approximately 2% over the past 12 months.

The European Medicines Agency stated that Kisunla can slow 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 give final approval for Kisunla, after which the drug will be available for use across the EU.

This positive opinion overturns the previous negative conclusion, similar to the situation when Leqembi was approved in the EU. Eli Lilly achieved this reversal by submitting new analytical data, collecting feedback from patients and healthcare professionals, and proposing a new dosing regimen along with additional measures to reduce the risk of ARIA.

This move pushes Eli Lilly and Eisai's competition in the Alzheimer's drug market into a new phase. The field has long been plagued by setbacks, safety concerns, and low market acceptance, leading Bloomberg Intelligence to halve its forecast for the market size by 2030 to $6 billion. According to predictions compiled by Bloomberg, Kisunla’s standalone sales could reach approximately $2 billion by then.

Both drugs clear toxic amyloid proteins from the brain through infusion, and while they can moderately slow disease progression, they are only approved for patients with early-stage Alzheimer's—a group that represents a small proportion of all patients. Additionally, both drugs have side effects, including the risk of potential brain swelling and bleeding.

Previously, Eli Lilly had obtained the approval for Kisunla to be marketed in the United States, Japan, and the United Kingdom. Compared with Leqembi, which is administered once every two weeks, Kisunla’s once-a-month infusion schedule may offer greater convenience.