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.
Eisai dials back forecasts for Alzheimer's drug Leqembi
Longer-term, Eisai and Biogen are hoping for further evidence to support Leqembi from the phase 3 AHEAD 3-45 trial, which started in 2020 and is underway in Japan, the US, and Europe and is enrolling people ages 55-80 who have not been diagnosed with Alzheimer's or another form of dementia. Results are due in 2028.
In the wake of a market pull in obesity nearly five years ago, the other shoe has dropped for Eisai’s serotonin 2C receptor ...
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
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Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages ...
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: ...
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
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