Eli Lilly's Alzheimer's Drug Kisunla Gets Limited Approval in Europe

The European Medicines Agency (EMA) has granted limited approval to Eli Lilly's Alzheimer's drug Kisunla, reversing an earlier decision to reject the drug due to concerns over brain swelling and bleeding in patients. The treatment will be administered via a monthly infusion and is aimed at patients with early-onset Alzheimer's who do not have a copy of the ApoE4 gene. Eli Lilly's stock has a consensus Strong Buy rating among analysts, with an average price target of $1,006.80, implying 26.02% upside from current levels.

The European Medicines Agency (EMA) has granted limited approval to Eli Lilly's Alzheimer's drug Kisunla, reversing an earlier decision to reject the drug due to concerns over brain swelling and bleeding in patients. The treatment will be administered via a monthly infusion and is aimed at patients with early-onset Alzheimer's who do not have a copy of the ApoE4 gene.

The EMA's Committee for Medicinal Products for Human Use (CHMP) initially recommended against the approval of Kisunla in March, citing the risk of potentially fatal events due to amyloid-related imaging abnormalities, involving swelling and potential bleeding in the brain. However, after Eli Lilly presented additional data, the CHMP has now backed the drug for use in certain patients with early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are apolipoprotein E 4 heterozygotes or non-carriers.

The European Commission, which generally follows the CHMP's advice, will now review the recommendation, with a decision expected in the coming months. The U.S. Food and Drug Administration (FDA) had previously approved Kisunla, an antibody drug given as a monthly intravenous infusion that studies show has slowed the progression of Alzheimer's disease.

Eli Lilly's stock has a consensus Strong Buy rating among analysts, with an average price target of $1,006.80, implying 26.02% upside from current levels.

References:
[1] https://www.marketscreener.com/news/eli-lilly-wins-chmp-backing-of-kisunla-alzheimer-s-drug-ce7c5fdbd980f522
[2] https://investor.lilly.com/news-releases/news-release-details/donanemab-receives-positive-opinion-committee-medicinal-products