The agency said the benefits do not outweigh the risks.
The European Medicines Agency has rejected Lilly’s Alzheimer’s drug Kisunlafor a license, saying its benefits don’t outweigh the risk of brain swelling or bleeding.
The treatment for early Alzheimer’s disease, which is administered via a monthly infusion, has been approved in the United States, United Kingdom, Japan and China.
But the European agency’s human medicines committee CHMP said today there is a risk of “potentially fatal events due to amyloid-related imaging abnormalities (ARIA).”
In a Phase 3 trial involving 1,700 people, Kisunla slowed cognitive decline by up to 35 percent in 18 months compared to a placebo group. But there were three deaths considered to be related to treatment, compared with one among those taking the placebo.
“Europeans living with early symptomatic Alzheimer’s disease and their loved ones urgently need additional treatment options. Today’s disappointing CHMP opinion means they must keep waiting,” Ilya Yuffa, executive vice president and president of Lilly International said.
Yuffa pointed out that Kisunla has been approved in other markets, adding that the company “remains confident” in its safety and effectiveness.
This class of drug is a new approach to treating Alzheimer’s disease, by targeting amyloid plaques that build up the brain. Only one other drug has been approved in this class in Europe, Eisai’s Leqembi (lecanemab). The EMA also rejected this drug last summer in its initial assessment, but backed it in November in a restricted population after a re-examination.
“We hope that through the re-examination process, we will be able to continue our discussions with the agency to bring donanemab to the millions of people across Europe suffering from this relentless, fatal disease,” Yuffa added.
