EU Regulators Reject Eli Lilly's Alzheimer's Drug: A Risky Decision?

The European Medicines Agency committee declined to approve Eli Lilly's Alzheimer’s treatment, citing risks of brain bleeding and swelling. The drug, Kisunla, has been approved in Japan, China, and by US regulators for early-stage dementia. Lilly seeks further discussion, referencing a similar reversal for Eisai's Leqembi.

The European Medicines Agency has rejected Eli Lilly's Alzheimer's treatment for the European market due to concerns over severe side effects, such as brain bleeding and swelling.

The EMA's committee concluded that despite its approval in the US for mild dementia cases, the drug's benefits do not outweigh its risks. This decision could impact Eli Lilly's market strategy, as they assert that dialogues with the EMA will continue.

Previously, a similar decision on Eisai's Leqembi was overturned by the EMA. Kisunla, along with Leqembi, targets amyloid plaque buildup in Alzheimer's patients, highlighting the need for ongoing research on the safety and efficacy of such treatments.

(With inputs from agencies.)