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.
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Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in EuropeBiogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal ...
The firm said Biogen partner Eisai’s request for the EMA’s CHMP to reexamine the MAA for lecanemab in amyloid-positive early Alzheimer’s disease has paid off with a positive recommendation that ...
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys ...
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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 ...
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