The European Medicines Agency (EMA) has provided conditional authorization for Eli Lilly’s Alzheimer’s medication, Kisunla, overturning a previous rejection due to concerns regarding the risks of brain swelling and bleeding associated with the treatment.
Revised approval reflects new safety measures
Kisunla, which is designed for patients in the early stages of Alzheimer’s disease and is administered through monthly infusions, has already received approval in several countries, including the United States, the United Kingdom, Japan, and China. Earlier this year, the EMA’s Committee for Medicinal Products for Human Use (CHMP) had turned down the drug, citing risks of “potentially fatal events due to amyloid-related imaging abnormalities (ARIA).”
However, following a request from Lilly for a reassessment, the CHMP has now suggested that Kisunla be granted marketing authorization specifically for patients who do not possess or have only one copy of the ApoE4 gene, which is linked to a higher likelihood of developing Alzheimer’s.
Controlled access and careful monitoring required
The EMA has stipulated that Kisunla should be administered under a controlled access program and only by physicians trained in recognizing and managing ARIA. To mitigate risks further, the agency has imposed stricter regulations on treatment cessation and mandated that patients initiate treatment with a lower dosage.
Considering the new dosage guidelines and additional risk management strategies, the EMA concluded that the benefits of Kisunla “outweigh its risks in noncarriers and people with just one copy of ApoE4.”
“This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across Europe,” said Patrik Jonsson, executive vice president and president of Lilly International. “Donanemab has the potential to make a meaningful difference for people living with early symptomatic Alzheimer’s disease.”