BioArctic: CHMP issues positive recommendation for approval of lecanemab in the EU - Redeye

Redeye is encouraged by today’s news that the CHMP, EMA's Committee for Medicinal Products for Human Use, has recommended Lecanemab for approval in “treatment of early Alzheimer’s disease in adult patients that are apolipoprotein Eε4 (ApoE ε4) heterozygotes or non-carriers” in the EU. In other words, CHMP follows the UK path in excluding the risk group ApoE4 homozygotes, which represents about 10-15% of Alzheimer's patients. The next step is an approval from the European Commission, likely in Q1 (within 67 days from now). We will return with a research update on Monday where we will discuss the Q3 report (no major news), the new FY2024 forecast from Eisai and the positive implications of the recommendation (and likely approval) in the EU.

Länk till analysen i sin helhet: https://www.redeye.se/research/1056935/bioarctic-chmp-issues-positive-recommendation-for-approval-of-lecanemab-in-the-eu?utm_source=finwire&utm_medium=RSS