Biogen's Leqembi Receives Positive Recommendation from European Regulatory Committee After Initial Rejection
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of lecanemab (Leqembi) for early Alzheimer's disease (search).
This positive opinion follows a previous rejection by the committee, which initially raised concerns about the drug's potential side effects outweighing its benefits.
Leqembi, developed by Eisai and co-marketed with Biogen, targets and clears sticky brain plaques associated with Alzheimer's disease (search).
A European regulatory committee has reversed its earlier decision and now recommends the approval of Biogen's Alzheimer's treatment, lecanemab. This decision comes after an initial rejection a few months prior, marking a significant step forward for the drug's potential availability in Europe.
Biogen announced Thursday that lecanemab, marketed as Leqembi in the United States, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The recommendation supports its use as a treatment for early Alzheimer’s disease. The reversal follows the CHMP's initial concerns in July, which centered on the balance between the drug's potential side effects and its impact on slowing the progression of the debilitating neurodegenerative disease.
Lecanemab, developed by Eisai and co-marketed with Biogen, is designed to clear amyloid plaques (search), a sticky protein deposit in the brain, which is a hallmark of Alzheimer's disease (search). Clinical trial data demonstrated that Leqembi slowed the decline in cognitive function, specifically memory and thinking, by several months in patients with early-stage Alzheimer's disease compared to those receiving a placebo. This outcome suggests a potential disease-modifying effect, addressing a critical unmet need in Alzheimer's treatment.
The decision by the CHMP is a crucial step towards making lecanemab available to patients in Europe who are living with early Alzheimer's disease (search). The drug offers a new therapeutic option that targets the underlying pathology of the disease, potentially slowing its progression and improving the quality of life for affected individuals and their families.