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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Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in EuropeThe CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
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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.
Why one trial participant's healthy birth after her CAR-T treatment for lupus is catching resesarchers' attention: ...
European regulators initially said in July that the drug's benefits did not outweigh its risks. View on euronews ...
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
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