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Investing.com -- Shares of BioArctic AB tumbled by 7% on Friday following news that the European Commission (EC) has requested further review of the company’s Alzheimer’s drug, lecanemab, by the Committee for Medicinal Products for Human Use (CHMP).
This development comes after the CHMP had previously issued a positive opinion in November 2024, recommending approval of the drug for the treatment of early Alzheimer’s disease.
The EC has raised two additional questions that will now be discussed at the CHMP meeting in February 2025.
The first question pertains to new safety information that emerged after the CHMP’s initial positive opinion, potentially necessitating an update to that opinion. The second concerns the clarity of risk minimization measures to ensure they are implemented correctly.
These discussions are essential before the EC can make a final decision on the Marketing Authorization Application for lecanemab.
Despite the regulatory setback, BioArctic’s partner Eisai has stated that the safety profile of lecanemab reported in clinical practice in the United States, Japan, and other countries is consistent with that in the approved labels, with no new safety signals identified.
Eisai remains confident that the information provided is clear and sufficient to address the EC’s requests and will continue to work with the authorities towards EU approval.
The analyst at RCB commented on the situation, "The EC intervention is a surprise and raises some risk that the CHMP could change its position again to the negative. However, BioArctic has confirmed that the real-world safety profile of Leqembi in markets where it has launched is consistent with the clinical trial data and no new safety signals have been identified."
"This issue will likely be resolved within the next few months, and we would anticipate the CHMP confirming its positive recommendation, but we recognize there’s a potential downside risk of non-approval," the analyst said in a note.
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