EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with early Alzheimer's disease, reversing its initial decision from four months ago.
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.
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.
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug
EU Gives Green Light: Leqembi on the Verge of Alzheimer's Approval
The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages of the disease. The approval is limited to those with certain genetic profiles.
European watchdog partially approves new Alzheimer's drug
Leqembi, developed by US multinational Biogen and Japanese-based Eisai, is the brand name of an active substance ... of ApoE4", a type of gene know as an important risk factor for Alzheimer's. Such patients are less likely to experience certain serious ...
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
EU regulator backs Eisai-Biogen Alzheimer’s drug
EU drugs regulator recommends approval of Leqembi for early Alzheimer's, pending European Commission acceptance, for specific patient group.
Biogen up 5% after EMA recommends Leqembi for early Alzheimer’s disease
EST Biogen (BIIB) up 5% after EMA recommends Leqembi for early Alzheimer’s disease Published first on TheFly – the ultimate
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.
Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease drug that the company developed with Japanese partner Eisai — reversing an earlier decision not to approve the drug.
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
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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EU Backs Leqembi: A Breakthrough in Alzheimer's Treatment
The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a ...