EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
EMA recommends Leqembi for treatment of early Alzheimer’s disease
After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease in patients who have only one or no copy of ApoE4,
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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s diseaseFollowing a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
Analysis of Leqembi's commercial potential and market outlook, with a focus on growth projections and investment ...
According to Eisai, the delay by the EMA has been made for procedural reasons, rather than any issues with the regulatory package for Leqembi (lecanemab), which has been approved in the US ...
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