Europe Approves Eisai-Biogen's Alzheimer's Drug 'Under Strict Conditions' After Initial Negative Opinion
The European Commission (EC) on Tuesday approved Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc.’s (NASDAQ:BIIB) amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab),
The Commission said it granted the approval under strict conditions.
Lecanemab is indicated for adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.
Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils (soluble Aβ aggregates) and targets and reduces Aβ plaques (insoluble Aβ aggregates).
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Protofibrils are a key toxic form of Aβ that accumulate in the brain and cause neuronal injury.
MCI due to AD and AD dementia currently affect an estimated 15.2 million and 6.9 million people in Europe, respectively.
Eisai leads lecanemab’s development and regulatory submissions globally. Biogen and Eisai co-commercialize and co-promote the product. Eisai has final decision-making authority.
In the EU (excluding the Nordic countries), Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the MA Holder.
In the Nordic countries, Eisai and BioArctic will co-promote the medicine, with Eisai distributing the product as the marketing application holder Holder.
In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion for lecanemab approval.
The committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular, the frequent occurrence of amyloid-related imaging abnormalities involving swelling and potential bleedings in the brain of patients who received Leqembi.
After re-examining its initial opinion, in November 2024, CHMP recommended granting marketing authorization.
Earlier this year, the FDA accepted Eisai and Biogen’s Biologics License Application (BLA) for lecanemab subcutaneous autoinjector for weekly maintenance dosing.
A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025.
Biogen said Leqembi’s fourth-quarter global in-market sales of approximately $87 million, including U.S. in-market sales of approximately $50 million, represented good continued sequential growth.
In March, the CHMP issued an opinion that does not recommend that Eli Lilly and Co’s (NYSE:LLY) donanemab be granted marketing authorization for early symptomatic Alzheimer’s disease. Lilly said it would seek re-examination by the CHMP.
Kisunla (donanemab) is used to treat adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.
Price Action: BIIB stock is up 0.46% at $117.52 at the last check on Wednesday.
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